What to know about the new ALS drug

Brian Wallach and his wife, Sandra Abrevaya, created the nonprofit group I AM ALS after Wallach was diagnosed with the disease. (Erin Hooley/Chicago Tribune/Getty Images)

Patients and advocates are celebrating the approval of a new treatment designed to slow the progression of ALS, a devastating neurogenerative disease that kills most people within five years. The drug, Relyvrio, is only the third ALS treatment cleared by the Food and Drug Administration in almost three decades and the first since 2017.

Brian Wallach, a former Obama administration official who founded the nonprofit group I AM ALS after being diagnosed with the disease, tweeted that the approval has provided “something that is really rare for us; real, tangible hope.”

But the FDA action also stirred controversy. Some people — including FDA staff and some of the agency’s own outside advisers — raised concerns about the clinical trial for the drug, saying it had flaws and that the data was not strong enough to warrant an approval.