In another accelerated approval quest, Biogen will send its ALS drug to the FDA despite inconclusive data
The controversial Aduhelm approval continues to reverberate in Biogen’s development strategy, as the FDA will review another CNS drug from the biotech despite clinical trial data likely to raise significant questions over its effect.
Regulators signaled they will take up Biogen’s pitch for tofersen to treat a genetic form of ALS, the company announced Tuesday morning, tabbing it for priority review and a decision date of Jan. 25, 2023. The agency is planning to convene its panel of experts in an advisory committee hearing, Biogen added, suggesting the drug’s approval is far from certain.
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