The Alzheimer's drug donanemab from pharmaceutical giant Eli Lilly is about to receive a green light from US regulatory agencies.
The advisory committee of 11 independent experts convened by the US Food and Drug Administration (FDA) unanimously voted that donanemab is an "effective" drug for treating Alzheimer's disease, and the benefits of this experimental treatment outweigh the risks.
Stronger therapeutic effect
Lilly's donamab is a new treatment method that slows down cognitive decline in early Alzheimer's disease patients by removing amyloid plaques associated with the disease.
For a long time, analysts have predicted that donanemab will surpass the only existing Alzheimer's disease treatment drug, Leqembi, because donanemab has higher efficacy in clinical trials and only needs to be administered once a month instead of every two weeks.
In the Phase III trial, compared to the placebo group, Leqembi slowed down cognitive decline by 27%, while Donanemab slowed down cognitive decline by 35%.
However, donanemab and similar drugs have safety issues related to brain swelling and cerebral hemorrhage, and three patients died due to brain swelling events.
In March of this year, the FDA requested a review of the drug and delayed its approval due to concerns about its safety as it may cause brain swelling. The FDA has decided to convene an external expert meeting to discuss the safety and efficacy of its drugs.
More data needed
Although the FDA's external advisory committee has recognized donanemab, the FDA still points out that more data is needed to understand the impact of the drug on patients with low or no Tau protein levels, as Lilly has excluded these patients from clinical trials.
Tau protein is a protein associated with Alzheimer's disease, and its level is one of the core indicators for diagnosing Alzheimer's disease.
Committee member and Cornell University professor Costantino Iadecola said, "If some subgroups require further analysis, then this drug should not be hindered from being made available to the public."
Nilufer Ertekin Taner, a neurogeneticist at the Mayo Foundation, stated that more data is needed for certain groups, such as those with Down syndrome.
The recommendations of this committee are not binding, but the FDA typically follows the recommendations of such committees.
Boosting stock prices
The support of this advisory committee is a boost for this pharmaceutical giant.
As of Monday's close, the company's stock price closed up 1.8%. On that day, the stock price reached a historic high, with a market value exceeding 800 billion US dollars.
Mark Mintun, Vice President of Neuroscience Research and Development at Lilly, stated that the company is "pleased that the committee unanimously recognizes Donanemab's pros and cons comparison.".