The FDA has approved Scholar Rock's Isembyld for spinal muscular atrophy, a rare neuromuscular disease. Isembyld is not the only approved therapy for SMA, but it is the first whose effect comes from acting on muscle tissue itself, according to MedCity News.
The approval gives Scholar Rock its first commercial product. The company is also testing the antibody in other rare muscle disorders, which could broaden its use beyond SMA.
Because this article draws on a single source, there are no differing reports to compare. The account stresses the drug's first-in-class nature and its commercial milestone for Scholar Rock.