Topline
A panel of experts advising the Food and Drug Administration could on Monday recommend Eli Lilly’s experimental Alzheimer’s drug donanemab for FDA approval, a closely watched decision that could pave the way for the drug to become the second of its kind authorized in the U.S.
Experts are weighing up donanemab, Eli Lilly's Alzheimer's drug.
Key Facts
The Peripheral and Central Nervous System Drugs Advisory Committee will meet on Monday to consider whether the benefits of Lilly’s drug outweigh its risks.
The FDA made a last-minute decision to consult an independent, external panel of experts on donanemab in March, a move that surprised observers just weeks before the agency was expected to rule on the drug and was a major blow to Lilly following a string of setbacks.
Data from Lilly’s clinical trial found donanemab, given by intravenous infusion once a month, slowed the progression of Alzheimer’s — which can include declining cognition, memory and language — by 29% compared to a placebo, though it also revealed risks for potentially serious side effects including brain swelling and bleeding.
Data and concerns surrounding donanemab are roughly in line with those for Leqembi, the brand name for Biogen and Eisai’s Alzheimer’s treatment lecanemab, which became the first fully authorized treatment for Alzheimer’s in the U.S. last year.
Both drugs — antibodies that combat the buildup of amyloid proteins in the brain that experts believe play a key role in Alzheimer’s disease — have been hailed as the heralds of a new era in Alzheimer's medicine after years of failing to develop treatments to meaningfully stop or reverse the terminal decline.
What To Watch For
The FDA is not required to follow the recommendations of its expert panels but it does put significant weight in their opinions. It is not clear when the FDA may make a final decision or how long it would take Lilly to roll out the treatment once approved. At least two analysts told Reuters they expect the FDA to eventually approve Lilly’s drug. If approved, the agency is likely to include similar warnings on the risks of side effects like brain bleeding and swelling and could possibly recommend regular MRI scans to assess brain health for those using them.
Key Background
If approved, donanemab would become the second FDA-approved Alzheimer’s drug of its kind on the market, after Leqembi. While celebrated as a major step forward for treating an incurable disease that affects nearly 7 million Americans, Leqembi has suffered from a disappointing rollout stymied by a controversial approval process and lingering questions over its effectiveness and side effects. These have left some doctors hesitant to prescribe the medication. Strict requirements — such as regular treatment infusions in a clinic and regular brain scans to check for side effects — and high costs have compounded the issue further, creating issues with insurers and public health providers. The matter is not unique to the U.S. and health funders in other countries like the U.K. also raised concerns over the ability to administer or afford such an expensive medication for a large portion of the population.
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Big Number
$13 billion. That’s how much Bloomberg Intelligence analysts predict the Alzheimer’s drug market could be worth by 2030. The figure, up from $250 million this year, is expected to be fought over by Lilly, Biogen and Eisai. Analysts expect Lilly to be able to capture half of this market despite its late arrival to market.
