Posted by Michael Wonder on 27 Jul 2020
Kyowa Kirin receives positive CHMP opinion for the expanded use of Crysvita (burosumab) to include older adolescents and adults for the treatment of X-linked hypophosphataemia
24 July 2020 - X-linked hypophosphataemia is a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints.
Kyowa Kirin today announced that the CHMP of the EMA has recommended the expanded approval of Crysvita (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphataemia (XLH). The European Commission has already granted a conditional marketing authorisation for Crysvita for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons.
The CHMP recommends that this approval is expanded to include all adolescents with radiographic evidence of bone disease, regardless of growth status, as well as adults with XLH. The CHMP opinion will now be reviewed by the European Commission, with a final decision expected in September 2020.
