Scholar Rock withdraws EU apitegromab filing after FDA flags Catalent Indiana plant with OAI inspection rating
SRRK•European filing withdrawn and Japan path clarified
In Europe, the apitegromab marketing authorization application was withdrawn to remove Catalent Indiana, and a resubmission is planned using the alternate site.
In Japan, PMDA aligned that no additional clinical studies are needed, and a JNDA filing is targeted by year-end 2026.
FDA review continues with alternate fill-finish site
Scholar Rock removed Catalent Indiana as an apitegromab fill-finish site from its FDA biologics license application following an OAI inspection classification.
FDA review continues with an alternate U.S. fill-finish facility, and an approval decision is due by the Sept. 30, 2026 PDUFA date.
Management expects to be ready to launch in the U.S. upon approval, citing existing commercial vial supply from the alternate facility.
