Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Bio­gen scored a big win at the FDA to­day as reg­u­la­tors ac­cept­ed their ap­pli­ca­tion for the con­tro­ver­sial Alzheimer’s drug ad­u­canum­ab and gave it a pri­or­i­ty re­view.

The PDU­FA date is March 7, 2021.

Sig­nif­i­cant­ly, Bio­gen says it did not use its pri­or­i­ty re­view vouch­er to win spe­cial treat­ment at the FDA. The agency hand­ed that out gratis.

That’s the ide­al sce­nario Bio­gen was look­ing for as dis­ap­point­ed an­a­lysts won­dered aloud about the de­layed ap­pli­ca­tion ear­li­er in the year.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.