ALS Association Supports FDA Reconsidering AMX0035 Decision

ALS Association Supports FDA Reconsidering AMX0035 Decision

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ALS Association Supports FDA Reconsidering AMX0035 Decision

The ALS Association is applauding the recent change of heart by the U.S. Food and Drug Administration (FDA) to consider AMX0035’s approval for amyotrophic lateral sclerosis (ALS) without requiring results from an additional clinical trial. Earlier this year, the agency had requested data from a placebo-controlled Phase 3 trial, PHOENIX (NCT05021536), before considering Amylyx Pharmaceuticals’ investigational oral therapy for approval. Following Amylyx’ upcoming, FDA-consented regulatory submission for AMX0035, the association urges that the therapy be approved as soon…

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