Amylyx Pharma: FDA Advisory Committee Supports Approval Of AMX0035 For Treatment Of ALS

(RTTNews) - Amylyx Pharmaceuticals Inc. (AMLX) announced that the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee or PCNSDAC voted that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of amyotrophic lateral sclerosis or ALS.

The PCNSDAC's decision was based on a review of all available evidence, including new analyses submitted for discussion at the September 7 meeting and the information presented at the March 30, 2022, PCNS meeting.

The company stated that the PCNSDAC recommendations, while not binding, will be considered by the FDA in its review of the pending New Drug Application (NDA) for AMX0035.

As previously reported, the Prescription Drug User Fee Act target action date for the NDA is September 29, 2022, which was extended by the FDA to allow more time to review additional analyses of data from the company's clinical studies.