BRIEF—Kyowa Kirin gets EU green light for self-administered Crysvita

Japanese drugmaker Kyowa Kirin says that its Crysvita (burosumab) has been approved for the option of self-administration in the European Union (EU) for the treatment of X-linked hypophosphatemia (XLH), a rare metabolic bone disease that impacts children and adults.

The approval means that some patients or carers may be suitable to administer Crysvita themselves, at the recommendation of the treating physician, in its licensed indication for the treatment of XLH in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.1

Crysvita has been available for clinical use since 2018. The first approval came from the European Commission, that granted a conditional marketing authorization for the treatment of XLH with radiographic evidence of bone disease in children one year of age and older and adolescents with growing skeletons. In 2020, this authorization was subsequently expanded to include older adolescents and adults.2

Crysvita is approved by the US Food and Drug Administration for patients with XLH aged six months and older and by Health Canada for patients with XLH aged one year and older.