Crysvita

burosumab

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Crysvita. The marketing authorisation holder for this medicinal product is Kyowa Kirin Holdings B.V.

The CHMP adopted a change and an extension to the existing indication as follows:1

“Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. in children 1 year of age and older and adolescents with growing skeletons.”.

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


1 New text in bold, removed text as strikethrough.

Key facts

Name
Crysvita
Agency product number
EMEA/H/C/004275
International non-proprietary name (INN) or common name
  • burosumab
Active substance
  • Burosumab
Therapeutic area
Hypophosphatemia, Familial
Hypophosphatemic Rickets, X-Linked Dominant
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
23/07/2020
Company name
Kyowa Kirin Holdings B.V.
Status
Positive
Application type
Post-authorisation

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