CAMBRIDGE Mass. (WBZ NewsRadio) — The Food and Drug Administration has approved a new drug for ALS from a Cambridge-based pharmaceutical company.
The drug Relyvrio, made by Amylyx Pharmaceuticals, was approved without any large-scale human trials. The FDA says about 20,000 people are living with the chronic disease in the United States, and about 5,000 new cases are diagnosed each year. ALS, also known as Lou Gehrig's Disease, has no known cure and is usually fatal. The FDA says Relyvrio helped slow down the progress of the disease in its human trial.
The new drug was pushed by a coalition of ALS patients, members of Congress, and others according to AP News.
The FDA did say in an online memo from 2019 that drugs for certain incurable diseases, like ALS, should get some "regulatory flexibility" because the medical needs of those patients are unmet.
The agency is already under federal scrutiny for its approval of Biogen's Aduhelm, a drug approved to treat Alzheimer's Disease with a questionable safety record.