Scholar Rock Removes Novo Nordisk Indiana Facility from FDA Application for Rare Muscle Weakness Drug

Scholar Rock announced it will remove Novo Nordisk's Indiana fill-finish facility from its FDA application for apitegromab, a rare spinal muscular atrophy treatment, after the site received an Official Action Indicated classification. The FDA previously rejected the drug in 2025 due to issues at this same facility. The review will now progress solely with a second U.S.-based facility, keeping the drug on track for a potential approval decision by the September 30, 2026 PDUFA action date.

Indiana facility BLA removal

• ▪The Indiana fill-finish facility was acquired by Novo Nordisk in 2024 following its acquisition of Catalent.
• ▪Scholar Rock announced on August 7, 2026, that it will remove the Catalent Indiana LLC fill-finish facility from its Biologics License Application for apitegromab.

FDA Official Action Indicated

• ▪Scholar Rock received notification on August 7, 2026, that the FDA classified the April 2026 inspection of the Catalent Indiana facility as Official Action Indicated.
• ▪The FDA previously declined to approve apitegromab in 2025, citing issues identified during a routine inspection of the Indiana fill-finish facility.

Second fill-finish facility review

• ▪Citi analysts stated that the second facility's regulatory standing, available inventory, and timely submission reassure them that it can support approval and launch.
• ▪Scholar Rock submitted the agreed-upon data package for its second fill-finish facility ahead of schedule following a March 2026 Type C meeting with the FDA.
• ▪Following the removal of the Indiana site, the FDA review of Scholar Rock's apitegromab application will progress solely with a second U.S.-based fill-finish facility.

September 30 PDUFA date

• ▪Scholar Rock is prepared to launch apitegromab in the United States immediately upon receiving FDA approval.
• ▪The FDA review of the apitegromab Biologics License Application remains on track for a potential approval decision by the September 30, 2026 PDUFA action date.

European Marketing Authorisation Application

• ▪Scholar Rock is engaging with the European Medicines Agency to include its second fill-finish facility in the apitegromab Marketing Authorisation Application.
• ▪Scholar Rock plans to provide updated European regulatory timelines once it aligns with the European Medicines Agency on the second facility's inclusion.