Ultragenyx and Kyowa Kirin announce MAA for KRN23 filed and accepted for review by EMA

• Ultragenyx Pharmaceutical (NASDAQ:RARE) and Kyowa Kirin International PLC, a wholly owned subsidiary of Kyowa Hakko Kirin Co. (OTCPK:KYKOF) announces that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for KRN23 for the treatment of X-linked Hypophosphatemia (XLH). An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in H2.
• KRN23 is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23).