FDA advisors question effectiveness of Biogen's ALS drug for rare form of the disease
TL;DR Summary
The FDA's independent panel of advisors voted against the effectiveness of Biogen's investigational ALS drug, Tofersen, for a rare and aggressive form of the disease. The drug failed to meet the primary and secondary endpoint in a phase three clinical trial, but the panel voted unanimously that the drug could have a clinical benefit in reducing a protein associated with disease severity. The FDA will make a final decision on April 25, and if approved, Biogen will study the drug further to verify its clinical benefits.
- FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the disease CNBC
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- FDA advisory panel recommends conditional approval of Biogen's drug for rare form of ALS STAT
- FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the disease CNBC
- Biogen ALS drug tofersen earns mixed voting by FDA advisors Seeking Alpha
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