Scholar Rock has resubmitted its Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for apitegromab to treat spinal muscular atrophy (SMA). The new application uses an alternate fill-finish facility to address a compliance issue with the previous application.
The company withdrew its prior application in August 2026 because of compliance issues at a Catalent facility. The alternate facility also supported the U.S. Food and Drug Administration’s approval of apitegromab, branded as ISEMBYLD, in September 2026.
Scholar Rock anticipates an opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2027.