Wednesday, August 4, 2021

Positive CHMP opinion for self-administered Crysvita




The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the rare metabolic bone disease X-linked hypophosphataemia (XLH).

XLH is a rare, genetic disease that causes bone, muscle and joint abnormalities. Although the condition is not life-threatening, it may reduce an individual’s quality of life with a life-long and progressive burden.

Currently, Crysvita (burosumab) is administered by subcutaneous injection, and will still need to be initiated by an experienced physician if the new self-administration option is ultimately approved.

Following this, if a patient is receiving a stable dose, their treating physician can then recommend that administration be performed by the patient or their carer following training.

The first self-administered dose will need to be conducted under the supervision of a healthcare professional, Kyowa Kirin added in a statement.

“Self-administration of medicines can help some patients maintain their independence and also empower them to take better control of their condition. In addition to XLH patients with mobility issues, this news could also be of benefit to parents of younger children with XLH, who may have less time to attend appointments at health centres or accommodate visits from home care nurses for administering injections,” said Raja Padidela, consultant paediatric endocrinologist at Royal Manchester Children’s Hospital, UK.

“Many injectable treatments for chronic diseases, such as insulin for the treatment of diabetes mellitus, are successfully self-administered by patients. For XLH patients, the treating physician will assess which patients are appropriate, ensuring those self-administering are competent and comfortable doing so,” he added.

Following the positive CHMP opinion, the European Commission (EC) will review the recommendation with a final decision on the self-administration option for Crysvita expected in the ‘coming months’.



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