Ahead of FDA committee to discuss new ALS drug, the jury remains out on how much benefit is enough for approval
Next week, an FDA advisory committee will face an all-too familiar question: Should a drug for a fatal, neurodegenerative disease be approved despite less than conclusive efficacy data?
It hasn’t been two full years since the panel faced a similar question in Biogen’s Alzheimer’s drug aducanumab. And it’s not unlike the 2016 debate over Sarepta’s first muscular dystrophy drug, either. In both scenarios, the FDA’s outside experts recommended against approval — unanimously in Biogen’s case — and in both scenarios, the agency greenlighted the drugs.
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