FDA Approves 6-Month LAI for Treatment of Schizophrenia in Adults

The US Food and Drug Administration (FDA) has approved Janssen Pharmaceutical’s INVEGA HAFYERA^TM (6-month paliperidone palmitate), a long-acting, atypical antipsychotic for adults with schizophrenia.

The 6-month paliperidone palmitate is the one-and-only, twice-yearly injectable therapy. Before beginning this treatment, patients must have been on 1-month paliperidone palmitate for at least 4 months or have received at least one 3-month injection cycle of 3-month paliperidone palmitate.

INVEGA HAFYERA is the latest, long-acting injectable (LAI) from Janssen, joining INVEGA SYSTENNAR^® (1-month paliperidone palmitate) and INVEGA TRINZA^® (3-month paliperidone palmitate) to offer a slow-dissolving injectable for 6 months of continuous treatment.

“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, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “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.”

INVEGA HAFYERA was evaluated in a 12-month, randomized, double-blind, noninferiority Phase 3 global study. This research included 702 adults living with schizophrenia, aged 18 to 70, from 20 countries. Study results examined the time-to-first relapse at the end of the 12-month period comparing INVEGA HAFYERA with INVEGA TRINZA. Of participants, 92.5% treated with INVEGA HAFYERA and 95.0% treated with INVEGA TRINZA did not have any symptom relapse at 12 months.

INVEGA HAFYERA is not indicated for individuals with dementia-related psychosis and should be administered by a licensed health care provider. The safety profile of INVEGA HAFYERA is consistent with previous studies relating to INVEGA SUSTENNA and INVEGA TRINZA.

Reference

Janssen announces U.S. FDA approval of INVEGA HAFYERA™ (6-month paliperidone palmitate), first and only twice-yearly treatment for adults with schizophrenia. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. September 1, 2021. Accessed September 1, 2021.