Biogen Outlines Aduhelm's Confirmatory Trial Plans, Data Expected In 2026

Biogen Inc BIIB and Eisai Co Ltd ESALY are looking to get initial data from the FDA-mandated confirmatory trial for its Alzheimer’s disease drug Aduhelm out in four years. 

• The companies will launch a global 1,300-person trial in May 2022 that will randomize early-stage Alzheimer’s patients to receive either Aduhelm or a placebo. 
• The plans see Biogen and partner Eisai submitting the final protocol of the trial for FDA review by next March.
• Related Link: Amid Shaky Launch Of Aduhelm, Biogen Mulls Substantial Layoffs: STAT News Report.
• The company said it will probably take about four years for the trial to generate results, pushing a final answer to 2026.
• The trial will also include a long-term extension to collect longer-term treatment data for up to 48 months.
• Biogen was given accelerated approval, meaning the company showed the drug acts on an important biological marker, reducing the sticky amyloid plaques that clump in Alzheimer’s patients’ brains.
• But the drug did not prove any activity benefitting the patients.
• The FDA requires Biogen to run a trial proving the benefit or the agency can request that Biogen pull the drug from the market.
• Price Action: BIIB shares are up 1.95% at $240.47 during the market session on the last check Thursday.