Posted by Michael Wonder on 31 Dec 2021
Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS
29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for AMX0035 (sodium phenylbutyrate and taurursodiol; also known as ursodoxicoltaurine)) for the treatment of amyotrophic lateral sclerosis.
The FDA has granted priority review and assigned a Prescription Drug User Fee Act date for AMX0035 of 29 June 2022, the target date by which the FDA intends to complete its review and take action on the new drug application.
