Biogen Submits Final Plan for Confirmatory Aduhelm Trial

Biogen Submits Final Plan for Confirmatory Aduhelm Trial

Source: 
BioSpace
snippet: 

Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).

The global biotech company, which focuses on neuroscience, expects its first patient to enter the trial's screening period in May 2022, should it receive approval. The study is expected to be completed in an accelerated timeframe of 4 years.