FDA Approves Janssen’s Invega Hayfera for Schizophrenia Treatment

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Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.

Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced that FDA approved their long-acting atypical antipsychotic Invega Hayfera (six-month paliperidone palmitate) for treatment of schizophrenia in adults on Sept. 1, 2021. Paliperidone palmitate is the first twice-yearly injectable for the treatment of schizophrenia in adults approved by FDA, according to a company press release.

The FDA approval follows a 12-month, randomized, double-blind, non-inferiority Phase III study that enrolled 702 adults (ages 18–70) living with schizophrenia from 20 countries. According to the press release, results showed non-inferiority of paliperidone palmitate compared to Invega Trinza (paliperidone), the company’s three-month injectable antipsychotic, on the primary endpoint of time to first relapse at the end of the 12-month period.

The results found that 92.5% of patients treated with paliperidone palmitate and 95% of those treated with paliperidone did not relapse within 12 months. Relapse was defined as psychiatric hospitalization, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, self-injury, violent behavior, or suicidal/homicidal ideation.

“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, medical director at ATP Clinical Research and six-month paliperidone palmitate clinical trial investigator, in the press release. “The Phase [III] trial results provide compelling evidence that [six]-month paliperidone palmitate offers longer-term symptom control with the fewest doses per year, which may support greater patient adherence.”


“Long-acting injectable treatments offer a number of advantages compared to oral medication for schizophrenia, including relief from needing to remember to take medication daily, lower discontinuation rates, and sustained treatment over longer periods,” said Bill Martin, global therapeutic area head, Neuroscience, Janssen Research & Development, in the press release. “Today’s approval enables us to rethink how we manage this chronic disease by offering patients and caregivers the potential for a life less defined by schizophrenia medication.”

Source: Janssen Pharmaceutical Companies