Kyowa Kirin gets extended EC approval for CRYSVITA in X-linked hypophosphataemia
Kyowa Kirin has secured extended approval for CRYSVITA (burosumab) from the European Commission (EC) in X-linked hypophosphataemia (XLH), to cover the treatment of older adolescents and adults.
Previously, CRYSVITA was approved for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children, aged one year and older and adolescents with growing skeletons, said the Japanese pharma company.
With the expanded approval, all adolescents with radiographic evidence of bone disease, irrespective of growth status, and also adults with X-linked hypophosphataemia are now eligible for treatment with the recombinant fully human monoclonal IgG1 antibody.
Considered as a life-long and progressive disease, X-linked hypophosphataemia presents typically in early childhood. The rare, genetic disease causes lower limb deformities, stunted growth, and bone and joint pain.
Abdul Mullick – President of Kyowa Kirin International said: “Today’s decision from the European Commission is a significant milestone for the management of XLH, a progressive and life-long disease that profoundly impacts the lives of both children and adults.
“As part of our commitment to life, we strive to answer the unmet medical needs of patients, their families, and the medical professionals who care for them. With this approval, older adolescents and adults with XLH will also be able to benefit from treatment with CRYSVITA, the only therapy that targets the underlying pathophysiology of this disease.
“We now will focus on ensuring access for as many people as possible in this expanded group of eligible patients.”
The extended approval for burosumab is based on the findings of the two phase 3 studies – the UX023-CL303 study in adults with XLH, and the UX023-CL304 study, which evaluated burosumab on osteomalacia (softening of the bones) in adults with XLH.
Kyowa Kirin has been collaborating with Ultragenyx Pharmaceutical in the global development and commercialization of CRYSVITA.