Ultragenyx And KKI Say MAA For KRN23 Filed And Accepted For Review By EMA

(RTTNews) - Ultragenyx Pharmaceutical Inc. (RARE) and Kyowa Kirin International PLC (KKI), a wholly owned subsidiary of Kyowa Hakko Kirin Co., Ltd., today announced that the European Medicines Agency or EMA has accepted for review the Marketing Authorization Application or MAA for KRN23 for the treatment of X-linked hypophosphatemia (XLH).

The MAA was filed and accepted in late 2016, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in the second half of 2017. Ultragenyx and Kyowa Hakko Kirin entered into a collaboration and license agreement in August 2013 to develop and commercialize KRN23.