Akeega - opinion on variation to marketing authorisation

Opinion

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

niraparib / abiraterone acetate

Opinion

On 29 January 2026, 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 Akeega. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.

The CHMP adopted a new indication as follows:

Akeega is indicated with prednisone or prednisolone:

• in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic).
• for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website 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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Note: New text in bold

CHMP post-authorisation summary of positive opinion for Akeega (EMAVR0000282377)

Adopted Reference Number: EMADOC-1700519818-2853904

Key facts

• Name of medicine:
  Akeega
• EMA product number:
  EMEA/H/C/005932
• Active substance:
  • abiraterone acetate
  • niraparib (tosilate monohydrate)
• International non-proprietary name (INN) or common name:
  • niraparib
  • abiraterone acetate
• Therapeutic area (MeSH):
  Prostatic Neoplasms, Castration-Resistant
• Anatomical therapeutical chemical (ATC) code:
  L01
• Marketing authorisation holder:
  Janssen-Cilag International N.V.
• Date of opinion:
  29/01/2026
• Status:
  Positive