Biogen Inc revealed surprise plans to seek U.S. regulatory approval for its Alzh...
- Biogen Inc revealed surprise plans to seek U.S. regulatory approval for its Alzheimer’s treatment aducanumab on Tuesday, saying new analysis of clinical trials showed promise, just months after it had shelved two studies.
Biogen and partner Eisai Co Ltd had in March decided to end two late-stage trials of aducanumab based on a so-called “futility analysis” of data, which revealed the trials had little hope of succeeding. The company said more data became available after the two studies that were discontinued in March, resulting in a larger dataset and a new analysis showed a positive outcome for the trial.
“The viability of such a filing is unknown, given the mixed results - in our view, Biogen is somewhat desperate for growth drivers...so a change in narrative is badly needed.”
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