October 5, 2020 – Kyowa Kirin Co., Ltd. today announced that the European Commission (EC) has approved CRYSVITA? (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia (XLH). CRYSVITA was previously approved for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons. With this expanded approval, all adolescents with radiographic evidence of bone disease, regardless of growth status, as well as adults with XLH are now also eligible for treatment with CRYSVITA.
“Until now, adults living with XLH have had limited treatment options for this progressive, disabling condition,” said Dr Karine Briot, H?pital Cochin, Paris, France. “Today’s approval is an important advance as it means that for the first time these adult XLH patients have a treatment option developed to target the underlying processes that cause this challenging disease.”
“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,” said Abdul Mullick, President of Kyowa Kirin International. “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.”
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