BIIB - Biogen files final protocol with FDA for Alzheimer's drug Aduhelm confirmatory trial

Biogen (NASDAQ:BIIB) said it submitted the final study protocol to the U.S. Food and Drug Administration for a confirmatory phase 4 ENVISION trial of its Alzheimer’s disease (AD) drug Aduhelm, developed with Eisai (OTCPK:ESALF) (OTCPK:ESALY). The company said the confirmatory study is a requirement based on FDA’s accelerated approval of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in early AD. Aduhelm has been a cause of concern for the company. In January, CMS had proposed to limit coverage of Aduhelm only for those currently enrolled in clinical trials. Meanwhile certain senators have urged CMS not to restrict coverage of the drug. Earlier in March, it was reported that Biogen laid off more than 100 workers — the vast majority in its Alzheimer's division — as a result of commercial failure of Aduhelm. Meanwhile, Biogen also amended its agreement with Eisai for the drug wherein it would take sole commercial rights for Aduhelm while will get

For further details see:

Biogen files final protocol with FDA for Alzheimer’s drug Aduhelm confirmatory trial