Janssen has secured FDA approval long-acting atypical antipsychotic Invega Hafyera (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.
The approval is based on the results of a 12-month, randomised, 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% of patients treated with Invega Hafyera and 95% treated with Invega Trinza were relapse-free at 12 months.
The safety profile observed in the trial was consistent with previous studies of Invega Sustenna and Invega Trinza with no new safety signals emerging.
“For too long, we’ve accepted relapse as a normal part of living with schizophrenia, while research continues to demonstrate that stronger medication adherence means better patient outcomes,” said Gustavo Alva, M.D., DFAPA, Medical Director at ATP Clinical Research and 6-month paliperidone palmitate clinical trial investigator.
“The Phase 3 trial results provide compelling evidence that 6-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”