Community update from Scholar Rock
Scholar Rock announced that the FDA has granted priority review for the Biologics License Application for apitegromab, an investigational muscle-targeted treatment developed to improve motor function for people living with SMA who are receiving an SMN-targeted treatment.
In parallel, the EMA has validated the Marketing Authorisation Application, which in now under review. Also, Scholar Rock informs that in the USA an active Expanded Access Program (EAP) for apitegromabin is available.