(Corrects to say Indiana facility of Novo Nordisk, not Catalent, in headline and paragraph 1)
By Sneha S K
Aug 7 (Reuters) – Scholar Rock said on Friday it would remove Novo Nordisk’s Indiana manufacturing facility from its application seeking FDA approval for a rare neuromuscular disease drug.
Last year, the U.S. Food and Drug Administration declined to approve the drug, apitegromab, citing issues identified during a routine inspection of the Indiana fill-finish facility — a third-party manufacturing facility that has been fully owned and operated by Novo Nordisk since 2024 following its acquisition of Catalent.
Here are some details:
• Scholar Rock is seeking approval for apitegromab as a treatment for spinal muscular atrophy, a rare genetic condition that causes muscle weakness and movement problems.
• It resubmitted its application to market the drug in March. That application included two fill-finish facilities: the Bloomington, Indiana facility and a second U.S.-based facility, which provided two independent paths to a potential FDA approval.
• The facility, owned by Novo Nordisk, informed the company on Friday that the FDA found significant compliance issues during its April inspection and that regulatory action may be required, leading Scholar Rock to remove the facility from its application.
• FDA review of the application will progress solely with the second fill-finish facility, the company said.
• Robust supply from the second fill-finish facility is available, it said.
• The fill-finish manufacturing process comprises filling and packaging services for syringes and injection pens in sterile conditions.
• Scholar Rock said a decision for approval for the drug remains on track for September 30.
• “The combination of regulatory standing, available inventory, and timely submission leaves us reassured that the facility can support approval and launch,” Citi analysts said, adding that securing approval by September 30 would improve confidence in eventual approvals elsewhere.
(Reporting by Sneha S K in Bengaluru; Editing by Shilpi Majumdar)
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