Unknown MAH — Akeega EMA EPAR public assessment report (EMEA/H/C/005932, 2023)
Johnson & Johnson · 2023 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted a positive opinion for Akeega, a fixed-dose combination of niraparib and abiraterone acetate, for treating mCRPC in patients with HRR gene alterations. Despite positive Phase 3 MAGNITUDE study results showing improved radiographic progression-free survival, accelerated assessment was not granted. The product, bioequivalent to co-administered single agents, combines niraparib and abiraterone acetate in a film-coated tablet, reducing pill burden. Safety concerns include higher rates of adverse events, particularly hematological toxicities (anemia, neutropenia), infections, and pulmonary embolism, compared to placebo. Two new adverse drug reactions, lymphopenia and pulmonary embolism, were identified.
Key findings — cited to the page
| Grade 3-4 hypertension incidence (control arm) | 12 % | MAGNITUDE (Study 64091742PRC3001) · p.192 |
| Grade 3-4 anaemia incidence (control arm) | 7.6 % | MAGNITUDE (Study 64091742PRC3001) · p.192 |
| Grade 3-4 AEs incidence (control arm) | 46.4 % | MAGNITUDE (Study 64091742PRC3001) · p.192 |
| Grade 3-4 hypertension incidence (niraparib arm) | 15 % | MAGNITUDE (Study 64091742PRC3001) · p.192 |
| Grade ≥3 AEs (Control arm) | 46.4 % | MAGNITUDE (Study 64091742PRC3001) · p.194 |
| Grade ≥3 AEs (Treatment arm) | 67.0 % | MAGNITUDE (Study 64091742PRC3001) · p.194 |
| subjects in 300-mg cohort experiencing Grade 4 neutropenia | 2 | Study 64091742PCR1001 (BEDIVERE) · p.83 |
| Grade 3-4 AEs incidence (niraparib arm) | 67 % | MAGNITUDE (Study 64091742PRC3001) · p.192 |
| Grade 3-4 anaemia incidence (niraparib arm) | 30 % | MAGNITUDE (Study 64091742PRC3001) · p.192 |
| Grade 3 increased ALT in placebo arm | 5.2 % | · p.184 |
| Grade 3-4 TEAEs in the SOC “Infections and infestations” in niraparib arm | 14.6 % | MAGNITUDE Cohort 1 · p.182 |
| Grade 3-4 TEAEs in the SOC “Infections and infestations” in placebo arm | 6.2 % | MAGNITUDE Cohort 1 · p.182 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →