Late Thursday, the Food and Drug Administration approved the use of Relyvrio to treat amyotrophic lateral sclerosis, more commonly known as ALS. Rosenblum said he's thrilled by the decision and immediately requested a prescription for it.
Bruce Rosenblum, an ALS patient and advocate, sits in his wheelchair.
Late Thursday, the Food and Drug Administration approved the use of Relyvrio to treat amyotrophic lateral sclerosis, more commonly known as ALS. Rosenblum said he's thrilled by the decision and immediately requested a prescription for it. Data on Relyvrio's effectiveness remains preliminary. A six-month trial in 137 patients, half of whom received a placebo and half the active drug, suggested Relyvrio could slow the rate of decline. A follow-up found that patients on the active drug lived longer than those who got the placebo.An FDA advisory committee voted in March that the data was too thin to justify approval, but in a second meeting earlier this month, the committee reversed its position and recommended approval.
Common side effects include diarrhea, abdominal pain, nausea and upper respiratory tract infection, but the drug appears relatively safe.Rosenblum, 63, a computer software entrepreneur who was diagnosed with ALS in 2017, said he's willing to try just about anything that promises to delay his decline.
He took the combination daily from last September until May, when the prescription ingredient was suddenly no longer available."Right now, I have no idea when I'm going to get it again," Rosenblum said."I've used up all I had, as have most patients I know. We're all waiting.
By the end of 2018, after taking the drug, then called AMX0035, he no longer needed a wheelchair and was able to travel again with his wife, walking"many miles" through parts of Europe, China and Tibet.
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