Johnson & Johnson (JNJ) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an indication extension for AKEEGA (niraparib and abiraterone acetate dual action tablet).
The recommendation is for niraparib and abiraterone acetate with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT) and BRCA1/2 mutations (germline and/or somatic).
The CHMP recommendation is based on positive results from the Phase 3 AMPLITUDE study, which evaluated the efficacy and safety of the niraparib/AAP combination compared with placebo plus AAP in 696 patients with mHSPC and HRR gene alteration.
The study demonstrated clinically meaningful and statistically significant improvements in its primary endpoint of radiographic progression-free survival (rPFS).
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.