Scholar Rock Removes Catalent Indiana As Commercial Fill-Finish Facility From Its Apitegromab BLA For The Treatment Of Spinal Muscular Atrophy Under Guidance From The FDA; Now On Track To Submit Apitegromab Japanese New Drug Application By End-2026
FDA review of BLA progressing well with Scholar Rock’s alternate fill-finish facilityCompany is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30,
Scholar Rock switched to a different factory to package their medicine after FDA feedback, and they're still on track to launch in the US and Japan soon. This shows the FDA is helping them move forward, even though they had to make a change.
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