Akeega FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 15, 2023.
FDA Approved: Yes (First approved August 11, 2023)
Brand name: Akeega
Generic name: abiraterone acetate and niraparib
Dosage form: Tablets
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prostate Cancer
Akeega (abiraterone acetate and niraparib) is a CYP17 inhibitor and a poly (ADP-ribose) polymerase (PARP) inhibitor combination indicated with prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC).
- Prostate cancer is a common cancer that starts in the gland cells of the prostate. Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that that no longer responds to androgen deprivation therapy and has spread to other parts of the body. Approximately 10 to 15 percent of patients with mCRPC have BRCA gene alterations. Patients with BRCA-positive mCRPC are more likely to have aggressive disease and may experience poor outcomes and a shorter survival time. The presence of a BRCA gene alteration can be detected by an FDA-approved test.
- Akeega is a combination of the androgen biosynthesis inhibitor abiraterone acetate, first approved by the FDA under the brand name Zytiga in 2011, and the PARP inhibitor niraparib, approved under the brand name Zejula in 2017 for the treatment of ovarian cancer in women. Abiraterone acetate works by targeting a protein called cytochrome P450 17A1 (CYP17A1) to decrease the production of the hormone testosterone which stimulates the growth of the cancer cells, and niraparib works to induce cytotoxicity in the cancer cells by inhibiting the PARP enzymes that play a role in DNA repair.
- FDA approval of Akeega was based on positive results of the Phase 3 MAGNITUDE study in which Akeega plus prednisone demonstrated a statistically-significant 47% risk reduction for radiographic progression-free survival (rPFS) compared to abiraterone acetate plus prednisone (AAP) in patients with BRCA-mutated mCRPC.
- Akeega tablets are administered orally once daily on an empty stomach in combination with 10 mg prednisone daily.
- Warnings and precautions associated with Akeega include myelodysplastic syndrome/acute myeloid leukemia; myelosuppression; hypokalemia, fluid retention, and cardiovascular adverse reactions; hepatotoxicity; adrenocortical insufficiency; hypoglycemia; increased fractures and mortality in combination with radium 223 dichloride; posterior reversible encephalopathy syndrome, and embryo-fetal toxicity.
- Common adverse reactions (≥10%), including laboratory abnormalities include decreased hemoglobin, decreased lymphocytes, decreased white blood cells, musculoskeletal pain, fatigue, decreased platelets, increased alkaline phosphatase, constipation, hypertension, nausea, decreased neutrophils, increased creatinine, increased potassium, decreased potassium, increased AST, increased ALT, edema, dyspnea, decreased appetite, vomiting, dizziness, COVID-19, headache, abdominal pain, hemorrhage, urinary tract infection, cough, insomnia, increased bilirubin, weight decreased, arrhythmia, fall, and pyrexia.
Development timeline for Akeega
| Date | Article |
|---|---|
| Aug 11, 2023 | Approval FDA Approves Akeega (niraparib and abiraterone acetate) for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer |
Further information
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