FDA Panel Now Recommending New ALS Drug After Earlier Rejection
A panel of external advisers to the U.S. Food and Drug Administration (FDA) voted on Sept. 7 to recommend a drug from Amylyx Pharmaceuticals to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease or motor neuron disease.
ALS is a progressive and fatal disease that has no known cure. It is a neurodegenerative disease, destroying nerve cells that are needed for basic functions like walking, talking, swallowing, and eventually breathing. The cause of ALS is largely unknown. The average life expectancy after diagnosis is two to five years.
The panel’s vote to recommend FDA approval comes after the same group in March voted to reject the same Amylyx drug—an oral drug called AMX0035. The drug comes as a powder that combines two older drugs: one prescription medication for liver disorders and a dietary supplement used in traditional Chinese medicine. The drug is approved under the name “Albrioza” with conditions to treat ALS in Canada….