The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding approval of Kyowa Kirin's Crysvita (burosumab) to include older adolescents and adults living with 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 is backing expansion of this approval to include older patients with radiographic evidence of bone disease, regardless of growth status.
XLH is a rare, life-long genetic disease that causes abnormalities in the bones, muscles and joints.
“Adult XLH patients’ response to conventional therapy, which includes phosphate and activated vitamin D, is variable and the evidence-base for its efficacy is limited,” said Dr Karine Briot, Hôpital Cochin, Paris, France.
“Having access to an efficacious treatment consistently from childhood through adulthood will be highly valuable to patients and to the physicians administering their care. [The] recommendation is an important step forward for all people with XLH and those who care for and support them.”
A final decision expected in September 2020.