FDA Approves Janssen’s Schizophrenia Injection Invega Trinza

Janssen Pharmaceuticals plans to make its long-acting atypical schizophrenia therapy Invega Trinza commercially available by mid-June, following FDA approval last week.

Invega Trinza (three-month paliperidone palmitate) is the first and only schizophrenia drug to be administered just four times a year, providing the longest dosing interval available, the company says. It was approved under a priority review which cuts the NDA review time from the standard 10 months to just six.

In a long-term Phase 3 maintenance trial, 93 percent of patients treated with the drug didn’t experience a significant return of schizophrenia symptoms.

Prior to starting Invega Trinza, patients must be adequately treated with Invega Sustenna (one-month paliperidone palmitate) for at least four months. Last November, the FDA approved two sNDAs for Invega Sustenna to treat patients with schizoaffective disorder. — Jonathon Shacat