Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. The recommendation covers clinically stable adults on 1-month paliperidone palmitate (PP1M) or 3-monthly paliperidone palmitate.
If approved by the European Commission, PP6M would be the first twice-yearly treatment for adults living with schizophrenia and the longest available dosing interval for an antipsychotic medication in the European economic area, according to a news release.
Treatment delivery comes through a long-acting injectable, which Janssen said allows for the slow release of medication to the blood and offers a number of advantages compared to oral medication.
“With only two injections per year, 6-monthly paliperidone palmitate has the potential to reduce the burden of taking medication frequently, giving eligible patients the opportunity to focus on other aspects of their life,” Ludovic de Beaucoudrey EMEA therapeutic area lead, Janssen Cilag, said in the release. “Today’s Positive Opinion from the CHMP underscores Janssen’s 60-year commitment to transforming the lives of people living with schizophrenia through rigorous scientific research and product development.”
Janssen based its authorization application on the Route 6 Study — a randomized, double-blind, non-inferiority Phase 3 global study. The study was meant to demonstrate that PP6M is not less effective than PP3M to prevent relapse in previously stabilized participants on a shorter-acting formulation of paliperidone palmitate.
The study enrolled 702 adults across several European countries and showed non-inferiority to PP3M on the primary endpoint of time to first relapse at the end of the 12 months.
“When it comes to the treatment of schizophrenia, unmet needs remain, including treatment adherence concerns, despite currently available therapies,” Janssen R&D global therapeutic area head of neuroscience Bill Martin said. “The positive opinion received from the CHMP today, enables us to rethink how we manage this chronic disease and brings us one step closer to offering patients and caregivers the potential for a life less defined by medication.”
