AKEEGA niraparib and abiraterone acetate

Drug Class

PARP inhibitor and CYP17 inhibitor fixed-dose combination

Mechanism

Niraparib inhibits PARP1/2-mediated DNA repair while abiraterone blocks CYP17-mediated androgen synthesis, synergistically targeting tumor cell growth in BRCA-mutated prostate cancer.

Approved Indication

Deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, and BRCA2-mutated metastatic castration-sensitive prostate cancer, per its FDA approval.

What This Means For Patients

AKEEGA is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2023) — Sources

Pivotal Clinical Evidence

• MAGNITUDE — Chi et al., J Clin Oncol 2023 (NCT03748641) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca-mutated-metastatic-castration
• https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217912