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# Scholar Rock Removes Catalent Facility from BLA to Advance Apitegromab
- URL: https://www.fdaweb.com/scholar-rock-removes-catalent-facility-from-bla-to-advance-apitegromab/
- Published: 2026-08-21T12:00:00.000Z
- Updated: 2026-09-14T12:05:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161663

Scholar Rock said Friday that it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy (SMA), removing a troubled Catalent (part of Novo Nordisk) facility from its BLA resubmission. The facility removal was recommended by FDA after Scholar added a second U.S.-based fill-finish manufacturing facility ([see earlier story](https://fdaweb.com/login.php?sa=v&aid=D5160910&cate=&stid=%241%24gn3.pW0.%24FnmkGmSLgGnkidZVvsV8c%2F&ref=fdaweb.com)).

“FDA review of the BLA is progressing well with the company’s alternate fill-finish facility, and Scholar Rock continues to expect an FDA approval decision by the September 30, 2026 Prescription Drug User Fee Act (PDUFA) date,” the company says.

Scholar Rock says it has sufficient commercial inventory of apitegromab vials produced at the alternate facility to support a U.S. launch if the drug is approved. The company said it is prepared to begin the launch in the third quarter following FDA approval.

The facility removal follows an FDA inspection of Catalent Indiana's facility in April ([see earlier story](https://fdaweb.com/login.php?sa=v&aid=D5161421&cate=&stid=%241%24M15.lk..%24H5lA32vPg1Cdeucgz1srf0&ref=fdaweb.com)), which the agency classified the inspection as Official Action Indicated (OAI). The facility has been under FDA scrutiny following a 2025 [Warning Letter](https://fdaweb.com/login.php?sa=v&aid=D5160398&cate=&stid=%241%242I0.hf0.%245cFRPnP.EvSG3am0a8GLi%2F&ref=fdaweb.com) that cited significant GMP violations after investigators found repeated failures to properly investigate contamination events and aseptic processing risks.

The facility has a history of compliance troubles. In 7/2025, FDA assigned an OAI classification to a recent inspection ([see story](https://fdaweb.com/login.php?sa=v&aid=D5160032&cate=&stid=%241%24t%2F..y42.%24cbaogaRYJw21UfIT5%2Fb1V0&ref=fdaweb.com)) that revealed significant GMP deficiencies. The serious compliance designation has delayed the approval and production timelines for drug products, including those from partner companies Regeneron and Scholar Rock.