Biogen Submits Final Protocol For Envision Trial Of Aduhelm On Alzheimer's Disease

(RTTNews) - Biogen Inc. (BIIB) said that it has submitted the final study protocol for the confirmatory envision trial of Alzheimer's disease drug, Aduhelm, to the U.S. Food and Drug Administration for review and approval.

The company expects the first patient to enter screening in May 2022 and the trial's primary completion approximately four years after the study begins.

The confirmatory trial is a requirement based on FDA's accelerated approval of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer's disease.

The study will be a global, placebo-controlled trial, aiming to enroll around 1,500 patients with early Alzheimer's disease and confirmation of amyloid beta pathology.

The company has also reaffirmed the trial's goal of recruiting at least 18 percent of patients in the U.S. from Black/African American and Latino communities.

Aduhelm is indicated for the treatment of Alzheimer's disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Aduhelm is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease.