BioMarin Says FDA Accepts Filing for Voxzogo's Full Approval in Children With Achondroplasia
BioMarin Pharmaceutical (BMRN) said Monday that the US Food and Drug Administration has accepted its supplemental new drug application seeking full approval of Voxzogo to treat children with achondroplasia. The regulator has set a Prescription Drug User Fee Act target action date of Feb. 28, 2027, the company said. The application was supported by long-term safety and efficacy data from three ongoing studies, including clinically meaningful results in growth and improvements across key skeletal growth-related measures, BioMarin said. Voxzogo was granted accelerated approval by the FDA in 2021. Shares of BioMarin were down more than 1% in early Monday trading.
BioMarin Pharmaceutical (BMRN) said Monday that the US Food and Drug Administration has accepted its supplemental new drug application seeking full approval of Voxzogo to treat children with achondroplasia.
The regulator has set a Prescription Drug User Fee Act target action date of Feb.
28, 2027, the company said.
The application was supported by long-term safety and efficacy data from three ongoing studies, including clinically meaningful results in growth and improvements across key skeletal growth-related measures, BioMarin said.
Voxzogo was granted accelerated approval by the FDA in 2021.
Shares of BioMarin were down more than 1% in early Monday trading.