Biogen files final protocol with FDA for Alzheimer’s drug Aduhelm confirmatory trial
Naeblys/iStock via Getty Images

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 Alzheimerâs disease (AD) drug Aduhelm, developed with Eisai (OTCPK:ESALF) (OTCPK:ESALY).
The company said the confirmatory study is a requirement based on FDAâs 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 â the vast majority in its Alzheimer's division â 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 Eisai.
Biogen said in a March 30 release that it expects the first patient to enter screening in May and the trialâs primary completion in ~4 years after the study begins.
The study expects to enroll ~1.5K patients with early AD and the company also reaffirmed the trialâs goal of recruiting at least 18% of patients in the U.S. from Black/African American and Latino communities.