PP 6M filed with FDA for schizophrenia.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) announced the submission of a supplemental New Drug Application (sNDA) to the FDA for PP 6M (paliperidone palmitate 6-month) for the treatment of adults diagnosed with schizophrenia. If approved, PP 6M will be the first and only long-acting injectable (LAI) schizophrenia medication with a twice-yearly dosing regimen. The submission is based on the Route 6 Study, a randomized, double-blind, non-inferiority Phase III global study that enrolled 702 adults living with schizophrenia from 20 countries. Data showed non-inferior efficacy of PP 6M compared to paliperidone palmitate 3-month (PP 3M) on the primary endpoint of time to relapse at the end of the 12-month period in both intent-to-treat and per-protocol analysis sets. The safety profile observed for PP 6M was consistent with previous studies of paliperidone palmitate 1-month (PP 1M) and 3-month (PP 3M) formulations with no new safety signals emerging. PP 6M is intended to be used only after patients have been stabilized on a shorter acting formulation of paliperidone palmitate (PP 1M or PP 3M), with the goal of administering fewer injections. The Janssen U.S. portfolio of LAI medicines currently approved to treat adults with schizophrenia includes Risperdal Consta (risperidone 2-weekly), Invega Sustenna and Invega Trinza (PP 1M and PP 3M formulations, respectively), all of which are administered in a clinical setting by a medical professional. Janssen plans to submit a Marketing Authorization Application extension to the European Medicines Agency (EMA) for PP6M in the coming months.