European Commission approves BYANNLI for management of schizophrenia in adults
pharmafile | November 23, 2021 | News story | Manufacturing and Production |
Johnson & Johnson have announced the approval of the long-acting atypical antipsychotic therapy BYANNLI® by the European Commission (EC), for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate (PP1M) or 3 monthly paliperidone palmitate (PP3M). This approval makes PP6M the first twice-yearly treatment for adults living with schizophrenia to be approved by the EC, with the longest available dosing interval for an antipsychotic medication in the European Economic Area.
“At Janssen, we are committed to reducing the devastating burden caused by mental illnesses,” shared Bill Martin, PhD, Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “Today’s approval of PP6M by the European Commission is a key milestone in our ongoing work towards this goal by offering patients and their loved ones the potential for a life less defined by schizophrenia medication.”
This approval is based on the randomised, double-blind, non-inferiority Phase III global Route 6 study. The study enrolled 702 adults living with schizophrenia in 20 countries, including Bulgaria, Czech Republic, France, Hungary, Italy, Poland, Russia, Spain and Turkey. The trial showed non-inferiority of PP6M compared with PP3M on the primary endpoint of time to first relapse at the end of the 12-month period. Results found that 92.5% treated with PP3M were relapse-free at 12 months.
The approval follows the positive CHMP opinion for PP6M, and the announcement of the FDA approval of PP6M for the treatment of schizophrenia in adults, after they have been adequately treated with PP1M for at least four months, or PP3M for at least one three-month cycle.
Six-monthly paliperidone palmitate (PP6M) is a long-acting injectable (LAI) that works by dissolving and entering the bloodstream slowly, due to its extremely low water solubility. This results in continuous absorption of paliperidone palmitate over a six-month period. This offers patients the potential for up to six months of symptom control, and a reduction in their risk of relapse with only two doses a year.
Ana Ovey
