Amylyx Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the FDA for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol (TURSO; also known as ursodoxicoltaurine)) for the treatment of amyotrophic lateral sclerosis (ALS).
“We are excited to share with the ALS community the exciting milestone that we have submitted our NDA to the FDA for review,” said Justin Klee, Co-CEO, Director and Co-Founder of Amylyx. Joshua Cohen, Co-CEO, Chairman and Co-Founder of Amylyx added, “Our team has worked and continues to work around the clock as we know time is of the essence for people living with ALS and their families. We will continue to keep the community closely updated on our progress.”
“We will continue to work closely with the FDA throughout the review process to move AMX0035 toward a potential regulatory approval as quickly and efficiently as possible,” said Tammy Sarnelli, Global Head of Regulatory Affairs of Amylyx. “We are so inspired by the people who participated in CENTAUR, the trial investigators, the ALS community and our partners and team, and we will continue to work tirelessly on behalf of you all.”
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