Industry Bulletins | February 7, 2022
European Commission Approves Janssen’s Byannli Twice-Yearly LAI Paliperidone Palmitate Treatment For Schizophrenia
The European Commission (EC) approved the Janssen Pharmaceutical Companies of Johnson & Johnson application for Byannli, a twice-yearly injection of paliperidone palmitate (PP6M), for the maintenance treatment of schizophrenia in adults who are clinically stable on one-monthly paliperidone palmitate (PP1M) or three-monthly paliperidone palmitate (PP3M). The approval is based on results from the Route 6 Study, which showed that 92.5% of consumers treated with PP6M were relapse-free at the end of the 12-month study.
EC approval is valid in all 27 member states of the European Union, and the European Economic Area countries (Norway . . .