Ultragenyx (NASDAQ:RARE) and collaboration partner Kyowa Kirin (OTCPK:KYKOF) announce plans to submit a supplemental marketing application to the FDA in H1 2020 seeking approval to use Crysvita (burosumab) to treat FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors (tumor-induced osteomalacia) that cannot be curatively resected or localized.
The companies are co-commercizing burosumab in the U.S. under a 2013 agreement.
The agency approved the FGF23-blocking antibody in April 2018 for X-linked hypophosphatemia.
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