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Major League Eating will part ways with 16-time champion Joey Chestnut ahead of this year’s annual Fourth of July hot dog eating contest, hosted by Nathan’s Famous.
The decision comes after Chestnut chose to represent a rival brand that sells plant-based hot dogs, the organization told CNBC in a statement.
Hot dog sales have been on the decline as wellness and health-conscious eating trends lead consumers away from processed foods to healthier alternatives.

Nathan’s Famous Fourth of July International Hot Dog-Eating Contest contestant Joey Chestnut stands next to the Nathan’s mascot Frankster, ahead of the official weigh in ceremony in the Manhattan borough of New York City, New York, U.S., July 2, 2021.
Angus Mordant | Reuters

The Nathan’s Famous Fourth of July hot dog eating contest will be down one dog this year.
Major League Eating announced Tuesday that it’s parting ways with 16-time champion Joey “Jaws” Chestnut ahead of this year’s competition, hosted by Nathan’s Famous.

Chestnut was previously offered a $1.2 million, four-year contract with MLE to participate in the hot dog competition, a source familiar with the matter told CNBC.
The decision to end the relationship comes after Chestnut chose to represent a rival brand that sells plant-based hot dogs, the organization told CNBC in a statement. The New York Post reported that the brand is Impossible Foods, though the company didn’t immediately provide a comment.
An account on X under Chestnut’s name late Tuesday said he was “gutted” to find out from the media that he was “banned” from Nathan’s hot dog eating contest this year. CNBC has not independently verified the account.
The post also said: “To set the record straight, I do not have a contract with MLE or Nathans and they are looking to change the rules from past years as it relates to other partners I can work with. This is apparently the basis on which I’m being banned, and it doesn’t impact the July 4th event.”
Impossible Foods offers plant-based hot dogs, which the company claims to be healthier and more eco-friendly than the traditional meat version, with half the saturated fat of the animal version and 84% less greenhouse gas emissions generated.

For nearly two decades, contestants, including Chestnut, have worked under the same “hot dog exclusivity provisions,” the MLE said in a statement.
“Joey is a great champion and a friend, and he is loved in Coney Island and all around the world. So I hope he’s there on July fourth as we celebrate Independence Day and he changes his choice to promote a veggie hot dog rather than ours,” Major League Eating President Richard Shea told CNBC.
The MLE said it worked with Nathan’s to accommodate Chestnut’s requests, including allowing him to compete in a rival unbranded hot dog eating contest on Labor Day to be streamed by an unnamed major platform.
Joey Chestnut holds the Guinness World Record for eating the most hot dogs in 10 minutes, a title he won at the annual hot dog eating contest in 2021. 
Nathan’s Famous Hot Dog Eating Contest in Coney Island, New York, is a Fourth of July tradition and broadcast nationally on ESPN. It’s also a marketing strategy for Nathan’s Famous, whose signature offering, the hot dog, is on a decline.
Particularly with the rise of health-conscious eating habits and the increasing importance of the wellness trend for consumers, the American staple food hot dog is one of many processed foods whose sales have been hurting.

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National Amusements has stopped talks with Skydance on a proposed merger with Paramount Global, sources told CNBC’s David Faber.
The deal was awaiting signoff from Shari Redstone, the controlling shareholder of Paramount.
Paramount shares closed nearly 8% lower Tuesday.

The Paramount Studios in Los Angeles, California, US on Monday, April 29, 2024. 
Eric Thayer | Bloomberg | Getty Images

National Amusements has stopped talks with Skydance on a proposed merger with Paramount Global, ending months of deal discussions without a transaction.
National Amusements, which is owned by Shari Redstone, the controlling shareholder of Paramount, had previously agreed to economic terms on a merger with a consortium that includes David Ellison’s Skydance, and private equity firms RedBird Capital and KKR. The deal had been awaiting signoff from Redstone, CNBC previously reported. National Amusements, which Redstone controls, owns 77% of class A Paramount shares.

Paramount shares closed nearly 8% lower Tuesday following the report.
National Amusements said in a statement on Tuesday it has “not been able to reach mutually acceptable terms regarding the potential transaction with Skydance Media for the acquisition of a controlling stake in NAI.”
“NAI is grateful to Skydance for their months of work in pursuing this potential transaction and looks forward to the ongoing, successful production collaboration between Paramount and Skydance,” the statement said.
Redstone’s company said it “supports the recently announced strategic plan being executed by Paramount’s Office of the CEO as well as their ongoing work and that of the Company’s Board of Directors to continue to explore opportunities to drive value creation for all Paramount shareholders.”
Paramount declined to comment. Spokespeople for Skydance and Redbird did not immediately respond to requests for comment.

The Wall Street Journal earlier reported talks had ended.
“While National Amusements had agreed to the economic terms that Skydance offered, there were other outstanding terms on which they could not come to agreement,” a NAI spokesperson said.
There’s been a disconnect on why the discussions didn’t amount to a deal, according to people familiar with the matter, showcasing the nature of the process that has gone on for months with various twists and turns.
Redstone and the special committee had asked for a so-called majority of the minority vote as part of the deal, a clause the Skydance bidding consortium found unacceptable and impracticable to add after deal talks had long started, according to people familiar with the matter. The special committee’s approval process, meant to determine the deal’s fairness, negated the need for such a vote, according to those familiar with Ellison’s thinking.
The Skydance bidding consortium instead blamed Redstone’s inability to let go of a family asset, her desire for more money for NAI, and private comments critical of David Ellison from Paramount board member Charles Phillips as likely reasons a deal collapsed, according to people familiar with the matter. A spokesperson for Phillips declined to comment.
The Special Committee of the Board of Directors of Paramount Global said, “The Special Committee met on Tuesday to discuss progress of discussions regarding a potential transaction with Skydance Media. At that time, the Special Committee was informed by a representative of National Amusements, Inc. that it did not have an agreement on a deal with Skydance Media and didn’t anticipate a path forward on this transaction. The Special Committee did not vote on any potential transaction.”

Moving forward

The about face on the proposed deal not only comes days after Skydance and Paramount agreed to merger terms, but also after Paramount’s annual shareholder meeting, where the company’s leadership outlined plans for the future.
Last week, Paramount’s current leadership, the so-called “Office of the CEO” — CBS CEO George Cheeks, Paramount Media Networks CEO Chris McCarthy and Paramount Pictures CEO Brian Robbins — mapped out the company’s strategic priorities in the event the company was not sold.
The shared leadership structure was put into place in late April, when former CEO Bob Bakish stepped down.
The trio outlined a plan that included exploring streaming joint venture opportunities with other media companies, eliminating $500 million in costs and divesting noncore assets. The plan that was presented to shareholders was Redstone’s alternative option if she chose not to sell.
While Redstone noted during the beginning of the shareholder presentation the unorthodox structure of the leadership team, she voiced her support. She has approved of their ideas and leadership during their short tenure, CNBC previously reported.
Redstone has controlled the future of Paramount and whether a sale would take place. She can now consider other offers for National Amusements from outside buyers.
In May, another potential buyer for Paramount surfaced — Apollo Global Management and Sony, which formally expressed interest in acquiring the company for $26 billion, CNBC previously reported. However, Redstone favored a deal that would keep the company together, and Apollo and Sony planned to break up Paramount, separating its movie studio from other parts of the business including its broadcast network, CNBC previously reported.
Under those terms, which were still being ironed out up until Tuesday, Redstone would have received $2 billion in cash for National Amusements, CNBC reported. Skydance would buy nearly 50% of class B Paramount shares at $15 apiece, or $4.5 billion, leaving the holders with equity in the new company. Skydance and RedBird would have also contributed $1.5 billion in cash to help reduce Paramount’s debt.
The plan outlined by Paramount’s three leaders last week emphasized the reduction of debt and getting the company back to an investment-grade rating after it was lowered to junk status earlier this year. Paramount had roughly $14.6 billion in long-term debt as of March 31. More

Tim Cook has an air of bashful reverence. In his 13 years at the helm of Apple he has created more value than just about any CEO in history, as the tech behemoth’s market capitalisation has climbed from less than $400bn to almost $3trn. But he still acts as if he were there thanks to the grace of Steve Jobs, or the skill of his colleagues, or divine providence. It was in character, then, that when he took to the stage at the iPhone-maker’s annual developers’ gathering on June 10th, he first greeted the cheering throng by clasping his hands together, as if in prayer. He probably would not admit this, but there was plenty to pray for.Apple is suffering one of its periodic bouts of investor angst. Call it the curse of the missing mojo. In the past 18 months Wall Street has convinced itself—as it has a few times since Jobs died in 2011—that the creative spark bequeathed by Apple’s Promethean co-founder has finally sputtered out. Behind that is a real problem: sales of the iPhone, which account for half of Apple’s revenues, are slowing. But there is a perception problem, too. Apple’s aloof response to the euphoria over generative artificial intelligence (AI) has cost it its crown as the world’s most valuable company, which it lost to its one-time nemesis, Microsoft. To make matters worse, the market value of Nvidia, maker of chips that power generative-AI tools, this month briefly overtook that of Apple. Its boss, Jensen Huang, is treated like the second coming of Jobs. More

General Motors is trimming its expected sales and production of all-electric vehicles this year, as U.S. adoption of EVs occurs slower than expected.
GM Chief Financial Officer Paul Jacobson said the company now expects production of 200,000 to 250,000 EVs this year, down from a previously announced range of 200,000 to 300,000.
The Detroit automaker is in the middle of launching its newest EVs, including its new entry-level Chevrolet Equinox EV.

GM’s 2024 Chevrolet Equinox EV during a media launch event for the vehicle in Detroit, May 16, 2024.
Michael Wayland / CNBC

DETROIT – General Motors is trimming its expected sales and production of all-electric vehicles this year, as U.S. adoption of EVs occurs slower than expected.
GM Chief Financial Officer Paul Jacobson said the company now expects production of its all-electric vehicles to range from 200,000 to 250,000 this year, down from a previously announced range of 200,000 to 300,000. The company has recently said it will produce volume to match demand, which is growing more slowly than had been forecast.

“So at the lower end of that, and I think it reflects the momentum that we have in the business,” Jacobson said Tuesday during a Deutsche Bank investor event.
Jacobson said GM expects EVs to make up 8% of U.S. sales industrywide this year. That’s lower than many other auto analyst forecasts, which expect EVs to represent around 10% of industry sales in 2024.
GM expects its EVs to be profitable on a production, or contribution-margin basis, once it reaches production of 200,000 units. That milestone is still expected in the fourth quarter of this year, he said.
Jacobson said the automaker, which does not report monthly sales, sold more than 9,500 EVs in North America in May. Sales of GM’s all-electric vehicles remained minuscule during the first quarter. EV sales totaled 16,425 units, or 2.8% of the automaker’s overall sales during the period.

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GM, Ford and Stellantis shares in 2024.

The Detroit automaker is in the middle of launching its newest EVs, including its new entry-level Chevrolet Equinox EV. The vehicle will start at around $35,000 before EV incentives, such as a federal credit of up to $7,500. GM also recently relaunched its Chevrolet Blazer EV after halting sales due to software issues.

The two new EVs, which share GM’s “Ultium” EV platform and technologies, are crucial for GM’s EV growth.
In addition to making the EVs announcement, Jacobson said the company expects its second-quarter earnings to be better than the first three months of the year. He also said the automaker this month will invest $850 million into its troubled Cruise autonomous vehicle unit to help with operational cash.
The comments by Jacobson come after the company on Tuesday morning announced that a new $6 billion stock repurchase authorization has been approved by its board, largely backed by sales of its traditional gas-powered vehicles.
The new buyback authorization comes as an accelerated $10 billion share repurchase program announced in November 2023 is expected to be completed by the end of June.
“We are very focused on the profitability of our [internal combustion engine] business, we’re growing and improving the profitability of our EV business and deploying our capital efficiently. This allows us to continue returning cash to shareholders,” Jacobson said in a release.

Correction: GM is trimming its EV production target to 200,000 to 250,000 vehicles in 2024. A prior version of this article misstated that range. More

Warner Bros. Discovery’s TNT Sports will be the exclusive broadcaster of the French Open in the U.S. beginning in 2025.
Before this deal, the games at Roland-Garros were broadcast in the U.S. by NBC and the Tennis Channel.
Warner Bros. Discovery has been upping the ante with sports offerings as the company continues negotiations to extend its partnership with the NBA.

Spain’s Rafael Nadal reacts as he plays against Germany’s Alexander Zverev during their men’s singles match on Court Philippe-Chatrier on day two of The French Open tennis tournament at The Roland Garros Complex in Paris on May 27, 2024. 
Anne-christine Poujoulat | AFP | Getty Images

Warner Bros. Discovery’s TNT Sports will be the new exclusive U.S. broadcaster of the French Open, also known as Roland-Garros, beginning in 2025, the company announced Tuesday.
The entertainment company signed a 10-year contract with the French Tennis Federation for an average of about $65 million per year, according to a person familiar with the matter.

The deal is set to make Warner Bros. Discovery the largest global broadcast partner to the Grand Slam tournament, which hosted 675,000 spectators this year. Warner Bros. Discovery-owned Eurosport has been broadcasting the French Open to 55 countries outside the U.S. since 1989, according to a press release.
“Roland-Garros perfectly aligns with our global sports strategy and our commitment to adding premium live sports content to our TNT Sports portfolio. We look forward to serving fans with a best-in-class content experience and providing them with direct access to more live Roland-Garros coverage than ever before,” TNT Sports Chairman and CEO Luis Silberwasser said in the release.
Per the agreement, the matches will be broadcast live on TNT, TBS and TruTV, including simulcasts on the company’s streaming platform Max.
Before this deal, the tournament was broadcast in the U.S. by Comcast’s NBC and streaming service Peacock and the Tennis Channel through a sublicensing deal.
TNT Sports announced it will have an on-site presence, including studio and announcing teams from multiple positions inside the Roland Garros Stadium in Paris, with further details on coverage to be announced in the coming months.

The news comes as Warner Bros. Discovery is launching a joint sports streaming service called Venu with Disney’s ESPN and Fox. Venu is set to launch this fall and will include TNT, TBS and TruTV in its offering of channels.
Adding the French Open is more evidence that the company wants to add live sports if the price makes sense for the investment. In the past three years, TNT Sports has acquired rights for the National Hockey League, NASCAR, U.S. Soccer, the College Football Playoffs (through a sublicensing deal with ESPN), and now the French Open.
Meanwhile, Warner Bros. Discovery is still in negotiations with the NBA to extend its partnership to broadcast live games. While NBCUniversal has made an offer for the package of games TNT Sports has been carrying, Warner Bros. Discovery is focusing on a different package of games, CNBC previously reported.
With the hangover from the Hollywood writers’ strike and cost-cutting measures across the industry, including at Warner Bros. Discovery, media giants have been leaning heavily on sports as a way to bring in bigger audiences and more advertising dollars.
Disclosure: Comcast is the parent company of NBCUniversal and CNBC.
— CNBC’s Alex Sherman contributed to this report.

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General Motors on Tuesday announced a new $6 billion stock repurchase authorization has been approved by its board.
The new buyback authorization comes as an accelerated $10 billion share repurchase program announced in November 2023 is expected to be completed by the end of this month.
Shares of GM were up 1% in premarket trading. The stock closed Monday at $47.57, up about 32.4% this year.

General Motors CEO Mary Barra, center, at the New York Stock Exchange, Nov. 17, 2022.
Source: NYSE

DETROIT – General Motors on Tuesday announced a new $6 billion stock repurchase authorization has been approved by its board.
The new buyback authorization comes as an accelerated $10 billion share repurchase program announced in November 2023 is expected to be completed by the end of this month.

“We are very focused on the profitability of our [internal combustion engine] business, we’re growing and improving the profitability of our EV business and deploying our capital efficiently. This allows us to continue returning cash to shareholders,” GM CFO Paul Jacobson said in a release.
The new authorization will allow GM to opportunistically repurchase shares after the completion of the existing reauthorization, the automaker said. A timeframe for completion of the program was not announced.
Shares of GM were up 1% in premarket trading. The stock closed Monday at $47.57, up about 32.4% this year.
The announced buyback plans come amid uncertainty surrounding the adoption of all-electric vehicles, which GM has bet heavily on, and stalling customer demand for new vehicles.  
“The investments GM made in its brands and product portfolio over the last several years, and the company’s operating discipline, are delivering consistently strong revenue growth, margins and free cash flow,” Jacobson said.

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United Auto Workers President Shawn Fain is under investigation by a federal court-appointed watchdog, according to a Monday court filing.
The monitor, Neil Barofsky, is investigating whether Fain abused his power as union president, potentially in violation of a 2020 consent decree between the UAW and the U.S. Department of Justice.
The union is in the middle of a national organizing drive of nonunion automakers.

United Auto Workers President Shawn Fain testifies about the toll of working hours on laborers before the Senate Health, Education, Labor and Pensions Committee in the Dirksen Senate Office Building on Capitol Hill in Washington, D.C., on March 14, 2024.
Chip Somodevilla | Getty Images

DETROIT — United Auto Workers President Shawn Fain is under investigation by a federal court-appointed watchdog who is tasked with monitoring the union and eliminating corruption, according to a Monday court filing.
The monitor, Neil Barofsky, is investigating whether Fain abused his power as union president. He also accuses union leaders, including Fain, of obstructing the investigation and interfering with his access to information.

Such actions could potentially violate a 2020 consent decree between the UAW and the U.S. Department of Justice that avoided a federal takeover of the union.
“The Monitor has attempted for months to garner the Union’s cooperation in gathering the information needed to conduct a full investigation, but the Union has effectively slow-rolled the Monitor’s access to requested documents,” the court filing reads.
More recently, the filing says the monitor expanded the investigation to include additional allegations of retaliation by Fain against one of the union’s vice presidents.
The monitor also opened an unrelated investigation into another unnamed UAW International Executive Board, or IEB, member, a regional director, after receiving allegations of potential embezzlement, according to the filing.

United Auto Workers President Shawn Fain (right) and UAW Secretary-Treasurer Margaret Mock (left) lead a march outside Stellantis’ Ram 1500 plant in Sterling Heights, Michigan, after the union called a strike at the plant on Oct. 23, 2023.
Michael Wayland / CNBC

Without specifically addressing any issues in the filing, Fain released a statement Monday night: “Taking our union in a new direction means sometimes you have to rock the boat, and that upsets some people who want to keep the status quo, but our membership expects better and deserves better than the old business as usual.

“We encourage the Monitor to investigate whatever claims are brought to their office, because we know what they’ll find: a UAW leadership committed to serving the membership, and running a democratic union. We’re staying focused on winning record contracts, growing our union, and fighting for economic and social justice on and off the job.”
The union is in the middle of a national organizing drive of nonunion automakers. The accusations follow Fain’s rise to international prominence after the union under his leadership scored record-setting contracts last year with General Motors, Ford Motor and Stellantis.
The court filing, which was first reported by The Detroit News, says Barofsky’s concerns largely began in February, after the monitor “began investigating current members of the IEB—including the President, Secretary-Treasurer, and one of the Union’s Regional Directors.”
The probe stems from union leaders removing all responsibilities assigned to Secretary-Treasurer Margaret Mock that were not constitutionally required amid allegations she had engaged in misconduct while carrying out her financial oversight responsibilities.
In response, the filing says Mock “lodged allegations of her own against the Union’s President that, among other things, the charges against her were false, and that the removal of her authority was improperly instigated in retaliation for her refusal or reluctance to authorize certain expenditures.”

The filing states more than three months after the monitor’s initial document request, the union has produced “a very small portion (approximately 2,600 documents) of the current potentially relevant pool of approximately 116,000—and with more than 80% of those documents only produced on June 6, 2024, days before the issuance of this report.”
The monitor believes the “union’s delay of relevant documents is obstructing and interfering with his access to information needed for his investigative work, and, if left unaddressed, is an apparent violation of the Consent Decree,” the filing reads.
The consent decree followed a yearslong corruption probe into the union involving embezzlement, bribery and other charges. It resulted in several convictions of union leaders and Fiat Chrysler executives, including two past union presidents.

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A panel of independent advisors to the FDA recommended Eli Lilly’s Alzheimer’s drug donanemab, paving the way for the treatment to receive full approval in the U.S. later this year.
If approved, Eli Lilly’s drug would become the second Alzheimer’s drug of its kind currently on the U.S. market after another treatment called Leqembi from Biogen and Eisai.
An approval would expand the treatment options for the more than 6 million Americans of all ages who have Alzheimer’s, the fifth-leading cause of death for adults over 65.

Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.’s shares climbed in early US trading after its experimental drug for Alzheimer’s slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval.
AJ Mast | Bloomberg | Getty Images

A panel of independent advisors to the Food and Drug Administration on Monday recommended Eli Lilly’s Alzheimer’s drug donanemab, paving the way for the treatment to receive full approval in the U.S. later this year.
The FDA typically follows the recommendations of its advisory panels but is not required to do so. If cleared for use, Eli Lilly’s donanemab would become the second Alzheimer’s drug of its kind currently on the U.S. market after another treatment called Leqembi from Biogen and its Japanese partner Eisai.

An approval would expand the now limited treatment options for the more than 6 million Americans who have Alzheimer’s, the fifth-leading cause of death for adults over 65.
In a first vote, 11 committee members unanimously said available data on the drug shows that it is effective at treating Alzheimer’s patients at the early stages of the mind-wasting disease. But several advisors noted that more data is needed on donanemab in Black and Hispanic patients, among other groups.
In a second vote, advisors unanimously said the benefits of Eli Lilly’s donanemab outweigh its risks. 
“There’s a huge unmet medical need here that hopefully can be addressed,” temporary committee member Sarah Dolan said during a meeting on Monday. Dolan is a consultant for the non-profit organization Critical Path Institute, which aims to improve the drug development process.
Eli Lilly is “pleased” with the panel’s recommendation and looks forward to bringing the treatment to patients, Mark Mintun, group vice president of neuroscience research and development at Eli Lilly, said in a statement.

The recommendation follows snags Eli Lilly faced in bringing the treatment to market.
The FDA in March called a last-minute meeting of an advisory panel to further review the safety and efficacy of Eli Lilly’s drug in a late-stage trial, just weeks before the agency’s deadline to rule on the treatment.
It was another blow to Eli Lilly, which initially expected donanameb to win approval at the end of last year. The FDA also rejected the drug in January last year, saying it had insufficient data to greenlight it. 
The FDA appears to be reviewing donanemab more cautiously after its polarizing approval of the ill-fated Alzheimer’s drug, Aduhelm, from Biogen and Eisai. The agency granted accelerated approval to that treatment despite a negative recommendation from an advisory panel.
Biogen and Eisai have since dropped the drug. 
Leqembi and donanemab are milestones in the treatment of Alzheimer’s after three decades of failed efforts to develop medicines that can fight the fatal disease. 
Both drugs are monoclonal antibodies that target amyloid plaque in the brain, considered a hallmark of Alzheimer’s, to slow the progression of the disease in patients at the early stages of it. 
But neither of the treatments are cures.
Drugs that target and clear amyloid plaque can also cause brain swelling and bleeding in patients, which in some cases can be severe and even fatal. Three patients who took Eli Lilly’s drug in a late-stage trial died from severe cases of those side effects, called amyloid-related imaging abnormalities, or ARIA.
A host of hurdles has slowed Leqembi’s rollout since its approval in July, including the steps needed to diagnose Alzheimer’s and monitor and handle the weekly infusions required with the drug. Biogen and Eisai signaled in April that they are seeing adoption pick up.
In a note Sunday, Leerink Partners analyst David Risinger said he expects limited commercial adoption of donanemab relative to Leqembi because Eli Lilly’s drug has “more safety liabilities” and will be less convenient, since it is administered once a month through the veins. That is a method known as intravenous infusion. 
Leqembi is currently administered through twice-monthly infusions, but Biogen expects to launch an injectable version of the drug next year, Risinger noted. He expects donanemab to rake in $500 million in sales by the end of the decade. 

How effective is Eli Lilly’s Alzheimer’s drug?

Eli Lilly’s phase three trial on more than 1,700 patients found that donanemab slowed the progression of Alzheimer’s by 29% compared to a placebo after around 18 months, based on a traditional tool used to measure the severity of dementia.
Those results are comparable to those seen with Leqembi. 
Patients in Eli Lilly’s phase three trial needed to test positive on a PET scan for amyloid plaque and another protein in the brain called tau, which is thought to be a marker of Alzheimer’s severity. People with no or very low levels of tau were not included in the primary analysis of the trial because researchers thought their disease was less likely to progress during the study. 
Eli Lilly’s trial mainly focused on patients with low-to-medium levels of tau, who appeared to benefit more from the treatment than those with high tau.

Westend61 | Westend61 | Getty Images

Eli Lilly argued that patients should be tested for amyloid plague to be eligible for the drug, but not for tau. The company said it tested for tau in the trial to enroll patients whose condition was expected to worsen, which made it more likely for the study to “clearly determine” the drug’s effect. 
Most advisors agreed that tau tests should not be required to access donanemab because it would likely restrict the population who can benefit from the drug.
“From a very practical perspective, I think this would be not a wise thing to to have as a barrier,” said temporary committee member Dr. Kathleen Poston, a professor in neurology, neurological sciences and neurosurgery at Stanford University, during the meeting on Monday.
Patients taking Eli Lilly’s drug in the trial were eligible to switch over to a placebo if amyloid levels in their brains fell below a certain threshold. By the end of the trial, 60% of participants on donanemab were able to stop treatment.
Dolan said allowing patients to discontinue the drug when enough amyloid has been cleared could be a “motivational factor” for patients to comply with their infusions and regular testing.

Risks of brain swelling, bleeding

Around 24% of trial participants who took donanemab experienced brain swelling, while 31% experienced brain bleeding. 
The majority of those ARIA cases were mild to moderate, as 6% of participants with brain swelling and 1% with brain bleeding experienced symptoms. They included headache, confusion, dizziness, nausea and in rare cases, seizures.
Serious cases occurred in 1.5% of patients with brain swelling and less than 1% with brain bleeding.
If donanemab is approved, FDA staff said they expect the drug’s label to include a strong “boxed” warning about the risks of brain swelling and bleeding, especially for people with two copies of a gene called ApoE4. They also expect recommendations for MRIs to monitor for those side effects in patients, among other strategies.
That is consistent with Leqembi’s approval label.
There were 19 deaths in participants on donanemab, including the three attributed to Eli Lilly’s drug, within the 18-month trial, according to a final analysis of data by FDA staff. That compares to 16 deaths in patients on placebo, reflecting a smaller imbalance in the number of deaths between people who took donanemab and those who didn’t. More