BioMarin seeks FDA nod to expand use of its Voxzogo treatment in children under five
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- BioMarin Pharmaceutical (NASDAQ:BMRN) on Tuesday said the U.S. Food and Drug Administration (FDA) had cleared expanding the use of its Voxzogo treatment in children with short stature under the age of five.
- The FDA accepted BMRN's supplemental new drug application and is set to decide on it by Oct. 21, 2023, or the so-called Prescription Drug User Fee Act date.
- The application was supported by results from a mid-stage study which showed similar safety and efficacy profiles for Voxzogo in children under five years of age as compared to those aged five and older.
- BioMarin (BMRN) stock earlier closed -0.9% at $93.42.