BioMarin Pharma: CHMP Adopts Positive Opinion To Expand Indication For VOXZOGO

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization to expand the indication for VOXZOGO for injection to treat children with achondroplasia aged 4 months and older whose epiphyses are not closed. A final decision is expected in the fourth quarter of 2023.

The company noted that VOXZOGO is currently approved in Europe in children with achondroplasia who are 2 years of age and older with open growth plates.

The FDA has also set a PDUFA Target Action Date of Oct. 21, 2023, for the sNDA for VOXZOGO to expand treatment in the United States to include children with achondroplasia under the age of 5 years.

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