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Approval Sought for Alzheimer's Drug

Eli Lilly has initiated a rolling submission to the US Food and Drug Administration to seek approval for its early-stage Alzheimer's disease drug, donanemab, according to the Wall Street Journal.

The Journal reports that Lilly did not initially expect to file for approval this year but decided to after the FDA approved aducanumab (Biogen's Aduhelm) under its accelerated pathway. Both drugs, it adds, aim to treat Alzheimer's disease by targeting and clearing amyloid plaques.

The Journal notes that Lilly will also be seeking approval for donanemab under the agency's accelerated pathway, as approval through that mechanism can be given based upon surrogate markers. Lilly reported donanemab lowered plaque levels in patients' brains in its mid-stage study while also slowing cognitive and function decline to a degree, the Journal adds.

The approval of Biogen's Aduhelm, though, was controversial as an advisory panel said there was not enough data to determine if drug worked and as there were reports of "off-the-books" meetings between Biogen and FDA officials.

But the Journal notes that Lilly is also hoping to set its drug apart from Biogen's and plans to conduct a head-to-head analysis.