BioMarin’s Voxzogo Accelerated Approval Based Mostly On One-Year Data

US FDA advisory committee had encouraged a two-year endpoint for achondroplasia treatments, but BioMarin attributes success to having ‘partnered closely’ with the agency. Confirmatory trial still being discussed.

Vosoritide approval (Nielsen Hobbs; the Pink Sheet | Alamy images)
• Source: Nielsen Hobbs; the Pink Sheet | Alamy images

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