Kyowa Kirin’s Crysvita secures CHMP support in rare X-linked hypophosphataemia
pharmafile | July 28, 2020 | News story | Manufacturing and Production, Sales and Marketing | CHMP, EMA
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has given its backing to Kyowa Kirin’s Crysvita (burosumab) to be used in the treatment of X-linked hypophosphataemia (XLH) for older adolescent and adult patients than it is currently approved for.
The committee said it supported expanding the existing European label for the therapy, which currently covers treatment of XLH with radiographic evidence of bone disease in children at least one year old and in adolescent patients with growing skeletons.
Should the recommendation be put into practice, Crysvita would be made available to all adolescent patients with radiographic evidence of bone disease, regardless of growth status, and all adults with XLH.
The CHMP opinion was given based on the findings of two Phase 3 trials which supported the drug’s safety and efficacy.
“There is currently no approved therapy in Europe for older adolescents and adults with XLH that targets the underlying cause of this debilitating, progressive and life-long disease,” commented Abdul Mullick, President of Kyowa Kirin International. “Should Crysvita be approved for expanded use, it will enable adolescents to continue to receive the benefits of treatment after their bones have stopped growing, and offer adults with XLH a treatment that has been shown to reduce pain and stiffness, improve physical functioning and mobility, and heal pseudofractures and fractures.“
The European Commission is now due to review the CHMP’s recommendation and will give its decision in September later this year.
Matt Fellows
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