Little is known about what causes or increases someone’s risk of developing ALS. Researchers think it’s only around 50% genetic, indicating that there are strong environmental and lifestyle risk factors affecting disease development. But very few of these risk factors have been identified.
Flanked by a bipartisan group of teary-eyed lawmakers, Minnesota Gov. Tim Walz on Monday signed into law a plan to fund $20 million in research into treating and curing ALS, a disease that is currently incurable and always fatal.
With a 6-4 vote, the group of independent advisers to the agency narrowly concluded that results from another clinical trial are needed to assess whether the therapy, called AMX0035, can help patients.
Results from a single clinical trial of an experimental drug for ALS developed by Amylyx Pharmaceuticals “may not be sufficiently persuasive” to support approval, according to a review of the drug posted Monday by officials with the Food and Drug Administration.
Biogen Inc. and Ionis Pharmaceuticals Inc. on Monday said they are ending development of a drug candidate for a form of amyotrophic lateral sclerosis, the paralyzing condition commonly known as Lou Gehrig's disease, following the failure of a Phase 1 study.