The Food and Drug Administration (FDA) has postponed the approval deadline for donanemab, the pharmaceutical company Eli Lilly’s experimental drug against Alzheimer’s disease.
Lilly applied to the FDA for approval of the drug in July, after data from the latest clinical trials showed that it slowed the progression of Alzheimer’s by 29% after 18 months, compared to a placebo.
The results were comparable to those obtained with Leqembi, a similar Alzheimer’s drug approved by the FDA last year.
According to a source familiar with the agency’s planning, the FDA was scheduled to make a decision on approving donamemab early next week.
(The experimental drug donanemab slows the progression of Alzheimer’s, according to a study)
However, in an “unexpected” move, it decided it wants to get input from its independent advisory committee before making a final decision, Lilly said in a statement Friday.
According to Lilly, the agency told the company that it wants to “better understand the issues” related to the drug’s safety and effectiveness. The FDA has not yet set a date for the advisory committee meeting, the statement added.
If Lilly’s drug had been approved, it would have been the third approval in the United States of a new type of Alzheimer’s drug aimed at slowing the progression of the disease. The others are Leqembi, from the Japanese pharmaceutical company Eisai and Biogen, the Massachusetts company, and Aduhelm, which is also developed by Biogen.
It is estimated that 6.7 million Americans over the age of 65 will suffer from this disease in 2023, according to the Alzheimer’s Association.
All three drugs are monoclonal antibodies that act against brain amyloid, which is considered a hallmark of Alzheimer’s disease.
(A new Alzheimer’s drug will cost $26,500 a year. Who will be able to afford it?)
Although the drugs appear to slow the disease in clinical trials, they have been hampered by concerns about potentially fatal side effects, such as brain inflammation and brain hemorrhages.
This group of anti-Alzheimer’s drugs has long been considered controversial.
Biogen’s Aduhelm won an accelerated version of approval in 2021.
That approval came even though the FDA advisory committee rejected the drug, saying there was not enough evidence to show it was effective in slowing the disease.
An 18-month congressional investigation later found that the FDA did not follow its own rules and that its approval of Aduhelm was “riddled with irregularities,” putting the agency under increased scrutiny.
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Additionally, Aduhelm initially cost $56,000 a year, threatening to raise Medicare premiums, before the company decided to cut that cost in half. With accelerated approval, the drug is only covered by Medicare if people are enrolled in a clinical trial.
The FDA never granted full approval to the drug, and earlier this year the company pulled it from the market.
