(Reuters) – A panel of outside advisers to the U.S. Food and Drug Administration on Wednesday voted against approving Amylyx Pharmaceuticals Inc’s drug for myotrophic lateral sclerosis (ALS), a neurodegenerative disease.
The FDA advisory committee voted 6 to 4 against the treatment, saying data from the clinical study conducted by the company failed to establish that the drug was effective in treating patients with the disease.
ALS, whose cause is largely unknown, weakens muscles and causes nerve cells in the brain and spinal cord to break down, affecting physical function and leading to severe disability and death.
(Reporting by Leroy Leo and Mrinalika Roy in Bengaluru; Editing by Shinjini Ganguli)
