Scholar Rock said on Friday it would remove Catalent’s Indiana manufacturing facility from its application seeking FDA approval for a rare neuromuscular disease drug.

Background

Last year, the U.S. Food and Drug Administration declined to approve the drug, apitegromab, citing issues identified during a routine inspection of Catalent’s Indiana fill-finish facility — a third-party manufacturing facility that was acquired by Novo Nordisk.

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.

The company resubmitted its application to market the drug in March. That application included two fill-finish facilities: Catalent Indiana and a second U.S.-based facility, which provided two independent paths to a potential FDA approval.

Catalent Indiana 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.

Scholar Rock said a decision for approval for the drug remains on track for September 30.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.