FDA approved the original biologics license application for ISEMBYLD on September 11, 2026. Today SCHOLAR ROCK INC holds the application (Drugs@FDA). FDA classed the original submission Type 1 - New Molecular Entity. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761463
- Sponsor
- SCHOLAR ROCK INC
- Original approval
- Review
- priority review
- Submission class
- Type 1 - New Molecular Entity
- Active ingredient
- apitegromab-mstn
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Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| apitegromab-mstn 150MG/3ML (50MG/ML) | INJECTABLE | INJECTION | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-26). Every field on this page comes from that record.
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