Amylyx: FDA to Reconvene to Review for AMX0035 for ALS on September 7

 Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) today announced that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS). The second virtual meeting of the PCNSDAC to discuss the AMX0035 NDA is scheduled, as published in the Federal Register, for September 7, 2022.

The PCNSDAC previously met on March 30, 2022, to discuss the NDA for AMX0035 for the treatment of ALS. The FDA is reconvening the committee to discuss the additional analyses of data from the Company’s clinical studies that were determined by the FDA to constitute a major amendment to the NDA. As a result, FDA extended the Prescription Drug User Fee Act (PDUFA) target action date for the AMX0035 NDA to September 29, 2022, from the original date of June 29, 2022.

“We are determined to do everything we can to bring AMX0035 to people living with ALS, and we look forward to another robust scientific discussion with the members of the advisory panel regarding the additional analyses from our clinical studies and the potential of AMX0035,” said Jamie Timmons, M.D., Head of Scientific Communications of Amylyx. “We remain confident in the data, including the recently published analyses supporting the previously reported functional and overall survival benefit for AMX0035. There is an urgent unmet need for new and effective treatments in ALS, and our team is working nonstop to continue our mission to end the suffering caused by neurodegenerative diseases.”

https://www.biospace.com/article/releases/amylyx-pharmaceuticals-announces-fda-advisory-committee-will-reconvene-to-review-new-drug-application-for-amx0035-for-the-treatment-of-als-on-september-7-2022/