Michel Vounatsos (Credit: World Economic Forum/Ciaran McCrickard)

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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