"The committee of outside experts voted 11-0 that donanemab’s benefits outweigh its risks. It also voted 11-0 that the data presented by Indianapolis-based Lilly showed the drug was effective.
One question the FDA will have to decide is whether treatment with Lilly’s drug can stop once its shown an effect. In Lilly’s trial, patients stopped receiving donanemab once amyloid plaques, thought by some to cause the disease, were largely cleared from their brains. Biogen and Eisai, in contrast, suggest that their amyloid-busting drug Leqembi be given indefinitely...
Lilly also compared the efficacy of its drug in patients with slightly earlier or more advanced disease, determined by how much of the protein tau had built up in their brain. It was more effective in patients with less tau and less advanced disease. "
But Kevin Krudys, a clinical efficacy reviewer at the FDA, said there is “considerable uncertainty” about how much amyloid needs to be reduced for benefit. Although Lilly said that amyloid was slow to reaccumulate when patients stopped taking donanemab, Krudys noted that data from a short period of the company’s study, and that Lilly did not include an appropriate comparison group.
Removing amyloid early in the course of the disease appears to modestly slow cognitive decline, but it can also cause signs of brain bleeding and swelling known as amyloid-related imaging abnormalities, or ARIA. Reisa Sperling, a neurologist and clinical investigator at Massachusetts General Hospital, said that ARIA seems to be a side effect inherent to the entire drug class."
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Congratulations, Weidong.