EMA's Advisory Panel Gives Thumbs Down To Amylyx Pharma's Amyotrophic Lateral Sclerosis Treatment

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Amylyx Pharmaceuticals Inc's AMLX conditional marketing authorization of AMX0035 (Albrioza) for amyotrophic lateral sclerosis (ALS).

The CHMP's opinion is contrary to the positive approvals from the FDA and Health Canada based on the strength of the CENTAUR trial data.

Amylyx disagrees with the CHMP's opinion and plans to request a formal re-examination of the Marketing Authorization Application (MAA) procedure.

The CENTAUR trial demonstrated that AMX0035 is the first ALS therapy to show functional benefit and improved overall survival in a longer-term analysis.

The safety profile of AMX0035 in the CENTAUR trial was generally well-tolerated, with gastrointestinal events occurring more frequently in the AMX0035 group.

The re-examination procedure is an approximately four-month process, which includes the appointment of a different rapporteur and co-rapporteur from the initial evaluation. 

At the end of the re-examination, the CHMP will adopt a final opinion.

ALS affects approximately 29,000 people in the U.S., and more than 30,000 people are estimated to be living with ALS in Europe (EU and the U.K.).

Price Action: AMLX shares are down 2.10% at $24.26 during the premarket session on the last check Friday.