Scholar Rock de-risks apitegromab’s global filings after PMDA Japan approval
Scholar Rock said it removed Catalent Indiana from all commercial fill-finish roles for apitegromab’s U.S. BLA, withdrew its European filing to use an alternate facility, and reached PMDA alignment to submit a Japanese application without new local trials. The changes de-risk apitegromab’s global regulatory rollout across the U.S., Europe and Japan.