Scholar Rock Removes Catalent Indiana As Commercial Fill-Finish Facility From Its Apitegromab BLA For The Treatment Of Spinal Muscular Atrophy Under Guidance From The FDA; Now On Track To Submit Apitegromab Japanese New Drug Application By End-2026
FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facility
Company is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 Prescription Drug User Fee Act (PDUFA) date; robust supply of apitegromab commercial vials from alternate fill-finish facility available upon FDA approval
Following Catalent Indiana Official Action Indicated (OAI) inspection classification by FDA, in alignment with European Medicines Agency (EMA), Scholar Rock has withdrawn apitegromab Marketing Authorisation Application (MAA) and will resubmit with alternate fill-finish facility to facilitate most expeditious path to Committee for Medicinal Products for Human Use (CHMP) opinion
Japan Pharmaceuticals and Medical Devices Agency (PMDA) has agreed no additional clinical studies required for apitegromab regulatory submission
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