BioCentury
ARTICLE | Product Development

With patient groups’ endorsement, Amylyx, FDA to discuss approval of ALS therapy

Two foundations are calling for ‘aggressive’ approval of a third therapy for the disease

October 2, 2020 8:08 PM UTC

With two patient groups petitioning for its ALS candidate to reach patients quickly, Amylyx is preparing a pitch to FDA based on data from the 137-patient CENTAUR trial that could give the venture-backed biotech a short path to a marketed drug.

Two foundations, the ALS Association and I AM ALS, believe CENTAUR is enough. They have collected more than 43,000 signatures since launching a petition in early September calling for FDA to forego the need for a Phase III trial and approve AMX0035 swiftly to treat amyotrophic lateral sclerosis. The therapy combines two small molecules, sodium phenylbutyrate and tauroursodeoxycholic acid, in a single product...

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Amylyx Pharmaceuticals Inc.