FDA OK's Janssen Pharmaceutical's INVEGA HAFYERA To Treat Adults With Schizophrenia - Quick Facts

Janssen Pharmaceutical, Inc., wholly-owned by Johnson & Johnson (JNJ), announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.

Before transitioning to INVEGA HAFYERA, patients must be adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate) for at least four months, or INVEGA TRINZA (3-month paliperidone palmitate) for at least one 3-month injection cycle.

The FDA approval of INVEGA HAFYERA is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries.

The results showed non-inferiority of INVEGA HAFYERA compared to INVEGA TRINZA on the primary endpoint of time to first relapse at the end of the 12-month period. Results found that 92.5 percent of patients treated with INVEGA HAFYERA and 95 percent treated with INVEGA TRINZA were relapse-free at 12 months.

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