The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eigh­teen days ago, vir­tu­al­ly all of the out­side ex­perts on an FDA ad­comm got to­geth­er to mug the agency’s Bil­ly Dunn and the Bio­gen team when they pre­sent­ed their up­beat as­sess­ment on ad­u­canum­ab. But here we are, more than 2 weeks lat­er, and the on­go­ing de­bate over that Alzheimer’s drug’s fate con­tin­ues un­abat­ed.

In­stead of sim­ply rul­ing out any chance of an ap­proval, the log­i­cal con­clu­sion based on what we heard dur­ing that ses­sion, a se­ries of ques­tion­able ap­provals that pre­ced­ed the con­tro­ver­sy over the agency’s re­cent EUA de­ci­sions has come back to haunt the FDA, where the pow­er of prece­dent is leav­ing an open­ing some ex­perts be­lieve can still be ex­ploit­ed by the big biotech.

Endpoints Premium

This article is for premium subscribers only

Upgrade to a premium subscription plan for unlimited access, and join our community of key biopharma players.