(Reuters) -The U.S. Food and Drug Administration has declined to approve Scholar Rock’s drug for a rare neuromuscular disease, citing issues at a third party manufacturing facility, the company said on Tuesday.
Shares of the company were halted.
The FDA’s so-called complete response letter is related to observations identified during a routine inspection of Catalent’s Indiana fill-finish facility which was acquired by Novo Nordisk, the company said.
The observation’s were not specific to the drug apitegromab, Scholar Rock said. Recent site inspections at the Indiana facility have brought issues to light for the FDA, resulting in delays and rejections for Regeneron’s drugs.
Scholar Rock said it will resubmit the application for the drug’s potential approval, upon Catalent’s successful remediation of the FDA observations.
(Reporting by Sriparna Roy, Christy Santhosh, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Shailesh Kuber)
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