FDA approves Isembyld, the first therapy worldwide to directly target muscle loss in spinal muscular atrophy
The FDA approved Isembyld (apitegromab-mstn) on September 14 for SMA patients aged 2 and older already on an SMN2-targeted therapy — the first SMA therapy worldwide to directly target muscle loss. Patients receive a 10 mg/kg infusion every four weeks; the drug carries an annual list price of about $310,000. This site offers no medical advice.
Verification note: Compiled from the FDA's official approval announcement and BioPharma Dive reporting; confirm details against the FDA's official label. This site does not provide medical advice.