FDA Approves BioMarin's VOXZOGO For Children Under 5 Years With Achondroplasia
Portfolio Pulse from Benzinga Newsdesk
The U.S. Food and Drug Administration (FDA) has approved BioMarin Pharmaceutical Inc.'s (NASDAQ:BMRN) supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) to increase linear growth in pediatric patients with achondroplasia. Previously, VOXZOGO was indicated for children who were 5 years of age and older. This expanded indication now includes children of all ages with open growth plates. The company has seen strong patient demand for the medicine worldwide and has secured increased fill-finish commitments in 2024 and beyond to meet this additional demand.

October 20, 2023 | 8:09 pm
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POSITIVE IMPACT
The FDA approval of BioMarin's VOXZOGO for children of all ages with achondroplasia could potentially increase the company's market share and revenues. The strong patient demand worldwide indicates a positive outlook for the company.
The FDA approval expands the target market for VOXZOGO, which could lead to increased sales and revenues for BioMarin. The strong patient demand worldwide also indicates a positive market response, which could further boost the company's financial performance.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100