Crysvita

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On 14 December 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1 marketing authorisation for the medicinal product Crysvita, intended for the treatment of X-linked hypophosphataemia. Crysvita was designated as an orphan medicinal product on 15 October 2014. The applicant for this medicinal product is Kyowa Kirin Limited.

Crysvita will be available as a solution for injection (10 mg/ml, 20 mg/ml and 30 mg/ml). The active substance of Crysvita is burosumab, a human monoclonal antibody that binds to and inhibits the activity of fibroblast growth factor 23 (ATC code: M05BX05). Inhibiting the activity of elevated serum fibroblast growth factor 23 in X-linked hypophosphataemia reduces the loss of phosphate from the kidney and other metabolic abnormalities, which are considered to be causative of the disease’s bone changes.

The benefits with Crysvita are its ability to reduce the loss of phosphate from the kidney, to improve abnormally low serum phosphate concentrations and to reduce the severity of rickets as shown in x-rays. The most common side effects are injection site reactions, headache, and pain in extremities.

The full indication is: "Crysvita is indicated for the treatment of X-linked hypophosphataemia with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons."

It is proposed that Crysvita be prescribed by physicians experienced in the management of patients with metabolic bone diseases.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

Name Language First published Last updated
CHMP summary of positive opinion for Crysvita (English only) 2017-12-15  

Key facts

Product details for Crysvita
NameCrysvita
INN or common name

burosumab

Therapeutic area Hypophosphatemia, FamilialHypophosphatemic Rickets, X-Linked Dominant
Active substance

burosumab

Date opinion adopted14/12/2017
Company name

Kyowa Kirin Limited

StatusPositive
Application typeInitial authorisation