Scholar Rock Holding is removing one Novo Nordisk-owned fill-finish facility from its biologics license application for apitegromab to treat spinal muscular atrophy, after the facility was flagged for possible enforcement by the Food and Drug Administration.
The biopharmaceutical company said the application will proceed with a second fill-finish facility -- a U.S.-based facility in good standing with the FDA and European regulators -- and is on track for potential FDA approval by Sept. 30.
Scholar Rock said it received a customer notification on Friday that the FDA classified the first fill-finish facility, a Novo Nordisk-owned site in Indiana, as Official Action Indicated following an April site inspection. The classification means that regulatory and/or administrative actions are recommended, according to the FDA.
"Scholar Rock will continue to collaborate closely with the FDA and under their guidance, will remove Catalent Indiana from the apitegromab BLA," the company said, referring to the Indiana facility. "FDA review of the apitegromab BLA will progress solely with the second fill-finish facility."
The site was previously owned by Catalent, a contract development and manufacturing organization. Catalent said that the site has been fully owned and operated by Novo Nordisk since December 2024 in a statement earlier this summer. It said it divested the site to Novo Nordisk as part of its acquisition by Novo Holdings.
Scholar Rock said Friday that it continues to engage with the European Medicines Agency on next steps to include the second facility in its European marketing authorization application for apitegromab.
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