Evkeeza - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

evinacumab

Opinion

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.

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¹New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Evkeeza (II-11)

AdoptedReference Number: EMA/CHMP/489254/2023

Key facts

• Name of medicine:
  Evkeeza
• EMA product number:
  EMEA/H/C/005449
• Active substance:
  Evinacumab
• International non-proprietary name (INN) or common name:
  evinacumab
• Therapeutic area (MeSH):
  Hypercholesterolemia
• Anatomical therapeutical chemical (ATC) code:
  C10AX
• 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.

• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  Ultragenyx Germany GmbH
• Date of opinion:
  09/11/2023
• Status:
  Positive