Kyowa Kirin has received approval in the EU for the self-administration option of its X-linked hypophosphataemia (XLH) treatment Crysvita.
Following the approval, some patients or carers may become suitable to administer Crysvita (burosumab) themselves in its licensed indication for the treatment of XLH in children and young people aged one to 17 years old with radiographic evidence of bone disease, and in adults.
Prior to this approval, Crysvita was approved to be administered by subcutaneous injection. The treatment will still need to be initiated by a clinician experience in the management of patients with metabolic bone diseases, Kyowa Kirin said in a statement.
Following this – if the patient is receiving a stable dose – the treating clinician can recommend that administration be performed by the patient or carer following the ‘appropriate training’.
The first self-administered Crysvita dose after drug initiation or dose change will also need to be conducted under the supervision of a healthcare professional (HCP).
“This approval is another significant milestone for the treatment of people living with XLH. Kyowa Kirin is committed to improving the lives of patients and their families by giving healthcare professionals better ways to care for them,” said Abdul Mullick, president of Kyowa Kirin International.
“By gaining EU approval for the self-administration of Crysvita, we have created another valuable option in the care of children, adolescents and adults with XLH. The self-administration of Crysvita is a great example of how Kyowa Kirin is meeting physician and patient needs and delivering on our purpose, to make people smile,” he added.
XLH is a rare genetic disease that causes abnormalities in the bones, muscles and joints. Although the condition is not life-threatening, its burden is life-long and progressive.