BioMarin seeks label expansion for achondroplasia drug; FDA lifts Inhibikase full clinical hold
BioMarin is looking to press its advantage in the achondroplasia, or dwarfism, drug space.
The California company said Tuesday afternoon the FDA will take up its application to expand the Voxzogo label into children younger than 5 years of age. Regulators will make their decision by Oct. 21.
BioMarin’s move came a day after competitor BridgeBio touted Phase II data for its own achondroplasia program and subsequently sought a $150 million stock offering. Voxzogo was originally approved in November 2021 for patients 5 years and older.
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