Rare disease developers seek broader label for Crysvita

15 January 2020

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Crysvita (burosumab) co-developers Ultragenyx (Nasdaq: RARE) and Kyowa Kirin (TYO: 4151) have submitted to the US regulator for an expanded label.

Following initial approval in FGF23-related hypophosphatemic rickets and osteomalacia, the firms are seeking to market the option for FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (TIO).

If accepted, the US Food and Drug Administration will provide a target action date for the submission next month.

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