Aug 21 (Reuters) – Scholar Rock said on Friday it withdrew its European application for the experimental spinal muscular atrophy drug and plans to resubmit it with a different manufacturing site after issues at a Novo Nordisk-owned facility.
Last year, the U.S. Food and Drug Administration declined to approve apitegromab after identifying manufacturing issues during an inspection of the Bloomington, Indiana facility, which has been operated by Novo since 2024 following its acquisition of Catalent.
• The company plans to resubmit the application with an alternative manufacturing site to support “the most expeditious path” to a review by the European Medicines Agency’s Committee for Medicinal Products for Human Use.
• Scholar Rock said it has also removed the Indiana facility from its U.S. FDA application, and continues to expect an approval decision by the regulator’s September 30 target action date.
• It added it has enough commercial supply from an alternative U.S. manufacturing site and is prepared to launch the drug immediately if approved.
• Japan’s drug regulator has said no additional studies in Japanese patients are needed before the company seeks approval for apitegromab.
• The company expects to file for approval in Japan by the end of 2026.
• Apitegromab met the main goal of a late-stage trial and could become the first treatment designed to directly improve muscle strength in people with spinal muscular atrophy if approved.
(Reporting by Sahil Pandey in Bengaluru; Editing by Vijay Kishore)
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