Voxzogo
Opinion
On 14 September 2023, 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 Voxzogo. The marketing authorisation holder for this medicinal product is BioMarin International Limited.
The CHMP adopted an extension to the existing indication to include treatment of achondroplasia in patients from 4 months of age. For information, the full indication for Voxzogo will be as follows1:
Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.
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.
1New text in bold
Key facts
| Name |
Voxzogo |
| Agency product number |
EMEA/H/C/005475 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Therapeutic area |
Achondroplasia
|
| 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. |
| 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 |
14/09/2023 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |