July decision date set for full approval of Eisai's Alzheimer's drug, with an adcomm coming too
The last time the FDA held an advisory committee meeting for an Alzheimer’s drug, Biogen’s Aduhelm (aducanumab) was unanimously rejected by the committee, and eventually led to multiple committee member resignations after Aduhelm won accelerated approval.
This time, with Eisai and Biogen’s Leqembi (lecanemab), the agency will look to clear that tenuous air, and show that amyloid-lowering drugs can provide clinical benefits. When that adcomm meeting will be held remains unknown, but Biogen announced late Sunday that a priority review decision on the full approval of its Alzheimer’s drug — likely clearing the way for broad CMS and insurer coverage — will be on or before July 6.
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