Posted by Michael Wonder on 26 Mar 2025
FDA grants priority review for biologics license application and EMA accepts marketing authorisation application for apitegromab as a treatment for spinal muscular atrophy
25 March 2025 - FDA to review BLA application under priority review, with a PDUFA date of 22 September 2025.
Scholar Rock today announced that the US FDA has accepted its biologics license application for apitegromab, an investigational muscle-targeted treatment that is being developed to provide clinically meaningful improvement in motor function for people living with spinal muscular atrophy who are receiving an SMN-targeted treatment.
