(Reuters) – Amylyx Pharmaceuticals said on Friday the European Union medicines regulator for the second time declined to recommend a marketing authorisation for the company’s drug to treat amyotrophic lateral sclerosis (ALS).
The decision comes after Amylyx in June requested a formal re-examination of the initial negative opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The company said it will focus on completing the late-stage study of the drug, based on which it will seek the EU’s approval, and detailed results are expected by mid-2024.
The drug, which has been approved by the U.S. Food and Drug Administration (FDA), is a combination of generic compounds sodium phenylbutyrate and taurursodiol that work together to prevent nerve cells in the brain and spinal cord from dying prematurely.
Amylyx’s drug has also been granted conditional approval in Canada.
ALS, also known as Lou Gehrig’s disease, breaks down nerve cells in the brain and spinal cord that make muscles work, leading to progressive paralysis and death. It affects more than 30,000 patients in the United States, according to patient advocacy group ALS Association.
Shares of the company fell about 5% in premarket trading on Friday.
(Reporting by Khushi Mandowara in Bengaluru; Editing by Sherry Jacob-Phillips)
