Treats deleterious or suspected deleterious BRCA2 -mutated ( … prostate cancer (mCSPC). NDA 216793, held by Janssen Biotech. Abiraterone Acetate; Niraparib Tosylate.
As of Nov 14, 2026, NDA 216793 (Akeega), held by Janssen Biotech, was first approved by FDA on Aug 11, 2023, with 1 approved supplement and 0 published complete response letters.
AKEEGA with prednisone is indicated for the treatment of adult patients with deleterious or suspected deleterious BRCA2 -mutated ( BRCA2 m) metastatic castration-sensitive prostate cancer (mCSPC).
| Dec 12, 2025 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Aug 11, 2023 | Original applicationNew combination · Priority review | Approved |
| Akeega500MG;EQ 50MG BASE · tablet;oral | Abiraterone Acetate; Niraparib Tosylate | RxReference drug |
| Akeega500MG;EQ 100MG BASE · tablet;oral | Abiraterone Acetate; Niraparib Tosylate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
