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Scholar Rock将印第安纳州Catalent作为Apitegroumab BLA的商业灌装-成品设施，用于在FDA的指导下治疗脊髓性肌萎缩症;现在有望在2026年底前提交Apitegroumab日本新药申请
2026-08-21 21:11
- 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Indicated (OAI) inspection classification by FDA, in alignment with European Medicines Agency (EMA), Scholar Rock has withdrawn apitegromab Marketing Authorisation Application (MAA) and will resubmit with alternate fill-finish facility to facilitate most expeditious path to Committee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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