Crysvita
Opinion
On 23 June 2022, 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 new indication for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphataemia.
For information, the full indications for Crysvita will therefore be 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.
Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.
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.
Key facts
| Name |
Crysvita |
| Agency product number |
EMEA/H/C/004275 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| 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 |
23/06/2022 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |