FDA approves Invega Hayfera (6-month paliperidone palmitate), first and only twice-yearly treatment for adults with schizophrenia – Janssen Pharmaceuticals

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the 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 is based on the results of a 12-month, randomized, double-blind, non-inferiority Phase III global study that enrolled 702 adults (ages 18-70) living with schizophrenia from 20 countries. The results showed non-inferiority of Invega Hayfera 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 Hayfera and 95 percent treated with Invega Trinza were relapse-free at 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.

The safety profile observed in the trial was consistent with previous studies of Invega Sustenna and Invega Trinza with no new safety signals emerging. The most common adverse reactions (?5%) in the Invega Hayfera clinical trial were upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

Recently, the National Council for Mental Wellbeing and the American Psychiatric Association updated their schizophrenia treatment guidance and guidelines to expand the recommended use of long-acting injectables for appropriate adult patients living with schizophrenia.

Janssen CarePath offers a comprehensive support program that helps patients get started on Invega Hayfera and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.