Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups
For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.
US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.