FDA Staff Indicates Potential Clinical Benefit for Biogen's Investigational ALS Drug
TL;DR Summary
FDA staff has said that Biogen's investigational ALS drug, Tofersen, may have a "clinical benefit" on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year. The FDA's accelerated approval designation is meant to allow for faster approval of drugs for serious conditions that fill an unmet medical need. The panel will examine mixed evidence from the trial related to Tofersen's effectiveness and safety, and vote on whether it demonstrates whether the drug will produce a clinical benefit in patients with the rare form of ALS.
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- Biogen Data Suggest ALS Drug Has Treatment Effect, FDA Staff Say Bloomberg
- FDA staff says safety issues with Biogen's ALS drug to not prevent approval Reuters.com
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