© Reuters. FILE PHOTO: Eli Lilly logo is shown on one of the company’s offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake/File Photo
By Julie Steenhuysen and Patrick Wingrove
(Reuters) -The U.S. Food and Drug Administration has delayed its decision on Eli Lilly (NYSE:)’s experimental treatment for early Alzheimer’s disease and will hold a meeting of outside experts to discuss its safety and efficacy, the company said.
This is the second regulatory delay for the drug, donanemab, after Lilly released clinical trial data last year that showed the treatment was safe and effective.
Lilly said no date has been set yet for the advisory committee meeting to discuss the medicine, but it could be several months before it is held.
The FDA had conducted advisory committee meetings before approving other Alzheimer’s drugs, such as Eisai and Biogen (NASDAQ:)’s’s Leqembi, which received standard authorization last year and works in a similar manner.
Friday’s move showed the agency was “doing its due diligence before the distribution of the drug to patients,” said Howard Fillit, co-founder of the Alzheimer’s Drug Discovery (NASDAQ:) Foundation.
Lilly had first expected a decision by the end of last year, but in November said the FDA pushed that back until the first quarter of 2024 because the agency needed more time to review the approval application.
The Indianapolis-based drugmaker said there was no change to its 2024 financial forecast.
Donanemab, given by infusion once a month, is designed to clear from the brain a sticky protein called amyloid tied to the fatal, memory-robbing disease.
“This was definitely unexpected for us,” Anne White, president of Lilly Neuroscience, said in an interview. She noted that the news came very late in the review process and said the company had been ready to launch the drug.
White said the FDA wants the expert panel to discuss some of the unique aspects of the clinical trial used in its request for a traditional FDA approval, including issues around efficacy and safety.
In the trial, participants could stop treatment as soon as brain imaging showed that the drug had cleared the amyloid.
The drug is associated with swelling and bleeding in the brain and three people on the treatment in the company’s trial have died.
The FDA also wants to review the implications of assessing patients based on levels of another Alzheimer’s-related protein called tau, which is closely linked with disease progression, White said.
“We don’t have a lot of details,” she said, noting that the agency has indicated a desire to move quickly. White said the agency will publish the meeting date in the Federal Register. They typically take place about two months after that publication.
“We certainly hope that after the advisory committee, they will make a decision quickly, and then we can make this medicine available to patients as we believe it should be,” White said.
The surprise delay follows the FDA’s decision a year ago not to grant the company an accelerated approval for the drug.
Lilly’s shares were down marginally at $775, while Biogen rose 3% to $226 in premarket hours.
More than 6 million Americans have Alzheimer’s, according to the Alzheimer’s Association.
Lilly said last year that donanemab was shown in a large clinical trial to slow progression of memory and thinking problems by 22% to 29% overall, depending on the rating scale used, which was roughly comparable to the 27% slowing seen with Leqembi.
In patients with low-to-medium levels of tau, the drug slowed disease progression by 35.1% compared with placebo, which was the main goal of the study.
Lilly’s late-stage study showed that brain swelling occurred in 24% of the donanemab treatment group. Brain bleeding occurred in 31% of the donanemab group and about 14% of the placebo group.
Analysts on average expect donanemab sales of $189.6 million in 2024, rising to $837 million next year, according to LSEG data. In February, Lilly forecast 2024 revenue of $40.4 billion to $41.6 billion, driven largely by its weight-loss and diabetes drugs.
