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FDA Approves First ALS Drug Since 2017

Some of the agency’s reviewers feel there isn't sufficient evidence to approve the medication.

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A recent New York Times article discussed the approval of a new treatment for A.L.S., a neurological disorder that leads to paralysis and death. However, there are questions pertaining to how effective the drug is as some reviewers believe there isn’t sufficient evidence that it prolongs life or slows the progression of the progressive neuromuscular disease.

Conceived about 10 years ago by two college students at Brown University, the drug’s scientific name is AMX0035, but it is marketed as Relyvrio by their company, Amylyx Pharmaceuticals.  It was approved by the FDA last Thursday after a campaign by patients and advocacy groups. Doctors who treat A.L.S. patients also pushed for the drug's approval via a letter to the FDA and testimony before an FDA advisory committee. The A.L.S. Association also contributed $2.2 million to the development and study of the drug, money that was raised from the viral 2014 Ice Bucket Challenge. Amylyx will use revenue generated from sales of the drug to repay 150% of the association’s grant for the funding of additional research.

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