First and Only Twice-Yearly Treatment for Schizophrenia Receives FDA Approval

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The US Food and Drug Administration (FDA) has approved Janssen Pharmaceutical’s long-acting atypical antipsychotic Invega Hayfera (6-month paliperidone palmitate), a one-of-a-kind twice-yearly injectable for the treatment of adults with schizophrenia.¹ Patients wishing to take Invega Hayfera must first be treated with Invega Sustenna (1-month paliperidone palmitate) for at least 4 months, or Invega Trinza (3-month paliperidone palmitate) for at least 1 injection cycle.

“The approval of Invega Hayfera builds on our 60-year legacy of delivering transformational medicines for adults living with schizophrenia,” said Mathai Mammen, MD, PhD, Global Head of Janssen Research & Development at Johnson & Johnson. “This approval further underscores our steadfast commitment to addressing critical unmet needs, including treatment adherence concerns, faced by adults living with schizophrenia.”¹

Invega Hayfera is a long-acting injectable treatment administered by a health care provider in the upper buttocks area every 6 months, which dissolves slowly into the bloodstream.

FDA approval was based on the results of a 12-month, randomized, double-blind, noninferiority phase 3 global study. The study enrolled 702 adults from 20 countries, aged 18 to 70, living with schizophrenia. The results showed noninferiority of Invega Hayfera compared to Invega Trinza on the primary endpoint of time to first relapse at the end of the 12-month period, with relapse 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. Results also found that 92.5% of patients treated with Invega Hayfera and 95% treated with Invega Trinza were relapse-free at 12 months.

“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, MD, DFAPA, the 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.”¹

The safety profile observed was consistent with previous studies of Invega Sustenna and Invega Trinza. The most common adverse reactions (≥5%) were upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

“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, PhD, Global Therapeutic Area Head of Neuroscience at Janssen Research & Development. “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.”¹

Reference

1. Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen announces US FDA approval of INVEGA HAFYERA™ (6-month paliperidone palmitate), first and only twice-yearly treatment for adults with schizophrenia. News release. September 1, 2021. https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-invega-hafyera-6-month-paliperidone-palmitate-first-and-only-twice-yearly-treatment-for-adults-with-schizophrenia-301366768.html