Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy

Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition.

The approval follows earlier setbacks caused by problems at the company's manufacturing facility, which had delayed the drug's development timeline.

The FDA clearance enables the company to commercialize the therapy in the United States, potentially expanding treatment options for patients with this genetic disorder.