Biogen Pulls European Application for Approval of Alzheimer's Drug Aduhelm

By Cecilia Butini

Biogen Inc. said Friday that it has withdrawn its application with the European Medicines Agency to receive regulatory approval for its Alzheimer's drug Aduhelm, after the agency said it wouldn't give a positive opinion on it.

The company had already received a negative opinion from EMA's Committee for Medicinal Products for Human Use in December and requested a re-examination of its marketing authorization application, it said.

The drug, a monoclonal antibody which is the first approved treatment against Alzheimer's, was approved by the U.S. Food and Drug Administration under an accelerated approval pathway. Its approval has generated debate among scientists, some of whom have expressed doubt over its efficacy.

Write to Cecilia Butini at [e-mail]

(END) Dow Jones Newswires

04-22-22 1115ET