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
The ALS Association and I AM ALS are calling for ‘aggressive’ approval of a third therapy for the disease.
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