Treats spinal muscular atrophy (SMA). BLA 761463, held by Scholar Rock Inc. Apitegromab-Mstn.
As of Nov 13, 2026, BLA 761463 (Isembyld), held by Scholar Rock Inc, was first approved by FDA on Sep 11, 2026, with 0 approved supplements and 1 published complete response letter.
ISEMBYLD is indicated for the treatment of spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 11, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 22, 2025 | BLA 761463Facility Inspections, Postmarketing Requirements Under 505(0)(3) | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Isembyld150MG/3ML (50MG/ML) · injectable;injection | Apitegromab-Mstn | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
