On 9 November 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 Evkeeza. The marketing authorisation holder for this medicinal product is Ultragenyx Germany GmbH.
The CHMP adopted an extension to the existing indication to include treatment of patients aged 5 years and older with homozygous familial hypercholesterolaemia (HoFH). For information, the full indications for Evkeeza will be as follows:1
Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescentpaediatric patients aged 512 years and older with homozygous familial hypercholesterolaemia (HoFH).
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, removed text as strikethrough
CHMP post-authorisation summary of positive opinion for Evkeeza (II-11)
English (EN) (93.66 KB - PDF)