Niraparib and abiraterone (Akeega)

Mechanism of action

A fixed dose combination of niraparib and abiraterone. Niraparib inhibits poly(ADP-ribose) polymerase (PARP) enzymes PARP-1 and PARP-2, which are involved in DNA repair. Inhibiting PARP-1 and PARP-2 may result in formation of PARP-DNA complexes, DNA damage, apoptosis, and cell death. PARP proteins utilize base-excision repair (BER) to identify and repair single strand DNA breaks. Abiraterone is an antiandrogen, androgen biosynthesis inhibitor, CYP17 inhibitor. Inhibits the 17 α-hydroxylase/C17,20-lyase (CYP17) enzyme that is required for androgen biosynthesis, leading to a decrease in androgen production in testicular, adrenal, and prostate tumor tissues.

Diseases for which it is established

• Prostate cancer, BRCA-mutated

History of changes in FDA indication

• 2023-08-11: Initial approval with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test. (Based on MAGNITUDE)

History of changes in EMA indication

• 2023-04-19: Initial authorisation for treatment of adult patients with prostate cancer.

Also known as

• Code name: CJNJ-67652000
• Brand name: Akeega