Sanofi aims for Nexviazyme approval in younger Pompe disease patients

In Sanofi's Baby-COMET trial, Nexviazyme met all primary and secondary endpoints, teeing it up for potential label expansion in Pompe disease. In the Baby-COMET trial, Nexviazyme met all primary and secondary endpoints, teeing it up for potential label expansion. Sanofi’s Pompe disease drug is already approved in infants after one year and older. Credit: Grand Warszawski / Shutterstock.com Sanofi’s Nexviazyme (avalglucosidase alfa) could be set for approval in younger children with Pompe disease after the Phase III Baby-COMET trial met its primary endpoint. In the single-arm, open-label study (NCT04910776), Nexviazyme met its primary endpoint of the proportion of treatment-naïve paediatric…

Source: Pharmaceutical Technology