The experimental Alzheimer’s drug donanemab from Eli Lilly & Co. got support from a group of outside advisors to the Food and Drug Administration on Monday, which was a step closer to getting approved in the U.S.
The members of the FDA advisory committee all voted “yes” when asked if the experimental drug has been shown to help people with mild cognitive impairment and mild dementia who have Alzheimer’s disease. In a second vote, everyone on the committee agreed that donanemab is better for that group of patients than it is harmful.
The FDA doesn’t have to do what the advisory committee says, but most of the time it does.
Donanemab approval would give people with Alzheimer’s who are in the early stages of the disease a new way to be treated. The Alzheimer’s Association says that about 7 million people in the U.S. have Alzheimer’s at this time.
It looks like the FDA will approve donanemab, but analysts are still not sure how well it will work against Biogen Inc. and Eisai Co.’s ESALF, -0.43% Leqembi, which was approved by the FDA last year. Instead of Leqembi, donanemab has been linked to more cases of amyloid-related imaging abnormalities, which can be very bad side effects like brain swelling and bleeding.
Alzheimer’s is marked by high levels of amyloid. Reisa Sperling, director of the Centre for Alzheimer Research and Treatment at Brigham and Women’s Hospital, told the FDA’s advisory committee Monday that it might not be possible to get those levels down without imaging problems related to amyloid. Sperling said that with donanemab and other similar treatments, “we haven’t hit the full home run” because of the risks. “But right now it is very important to do everything we can to make a difference” to slow the disease’s progress, she said.
But during the open public hearing part of the meeting, some people who were against donanemab and other drugs like it said the side effects should be taken more seriously. A senior research fellow at PharmedOut, a research and education project at Georgetown University Medical Centre, said that brain bleeding and swelling are “now hidden behind the benign acronym ARIA,” which stands for amyloid-related imaging abnormalities. Butler told the committee that the phrase “sounds like a problem with the imaging test.” They were seen in clinical trials, though, and she said that they “should be a flashing neon warning light.”
Analysts say that Donanemab’s dosing schedule might be better than Leqembi’s because the once-a-month infusion schedule might be easier on patients than the twice-weekly Leqembi infusion schedule. But Eisai and Biogen have recently taken steps to level the playing field. On Sunday, the companies said that the FDA had accepted Eisai’s application for approval of a maintenance dose of Leqembi that should be taken once a month.
The FDA also asked questions about the design of the donanemab clinical trial in the days before the meeting. In Lilly’s study, people who were given donanemab could switch to a sugar pill if their amyloid levels dropped below a certain level. Analysts say it’s hard to judge the benefits of stopping treatment for those types of patients because there isn’t a direct comparison group.
Lilly stock LLY, +1.77% went up 1.8% on Monday and is now up more than 48% for the year. The price of Biogen’s stock BIIB, +0.24% went up 0.2% on Monday. It has lost 12.7% so far this year.
