Alzheimer's quick OK, take two: FDA offers Biogen, Eisai a shortcut to a possible lecanemab approval
Biogen CEO Michel Vounatsos is departing under a dark and wide cloud created by the Aduhelm fiasco, which essentially destroyed any hope of any substantial return on sales. The new FDA chief believes that the controversial early OK of that drug has dinged the agency’s credibility, spurring some heavy criticism of the accelerated approval pathway among reformers in Congress. The amyloid hypothesis has been badly damaged. And the Phase III trial Biogen/Eisai are running on the follow-up Alzheimer’s drug lecanemab won’t read out until the fall.
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