Scholar Rock resubmits apitegromab MAA to EMA for SMA treatment
SRRK•Scholar Rock resubmitted its marketing authorization application to the EMA for apitegromab to treat children and adults with spinal muscular atrophy. The filing uses an alternate fill-finish site, replacing Catalent Indiana, and a CHMP opinion is expected in the first half of 2027.
1. Application resubmitted
Scholar Rock resubmitted its EMA marketing authorization application for apitegromab to treat children and adults with spinal muscular atrophy. The filing uses an alternate fill-finish site in place of Catalent Indiana, whose GMP compliance prompted withdrawal of the prior application.
2. Review timeline
A CHMP opinion is expected in the first half of 2027.
