BioMarin: FDA accepts sNDA to expand use of VOXZOGO for injection

BioMarin Pharmaceutical announced that the U.S. FDA has accepted the company’s supplemental New Drug Application for VOXZOGO for injection to expand treatment in the United States to include children with achondroplasia under the age of 5. Achondroplasia is the most common form of disproportionate short stature. The FDA has set a PDUFA target action date of October 21, 2023 for the sNDA.