FDA advisors back Lilly’s Alzheimer’s drug, setting stage for approval after delay

An FDA advisory committee gave its strong backing to Eli Lilly’s Alzheimer’s drug donanemab, giving further support for the agency’s expected approval after a surprise delay earlier this year.

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.

While the FDA doesn’t have to follow the committee’s recommendations, it often does, and a rejection of the treatment would be a surprise despite a decision by the agency in March to delay an approval decision. At that time, Lilly said the FDA had asked for more data on safety as well as its plans to let patients stop treatment once a key biomarker fell significantly.

During Monday’s debate on the drug, many of the panel’s experts noted that while donanemab came with risks, they thought those could be…
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