FDA approves twice yearly injection for treatment for adults with schizophrenia
USA: The U.S. Food and Drug Administration (FDA) has approved Invega Hafyera (paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. The manufacturing authorisation of 6-month injection form of the long-acting atypical antipsychotic paliperidone palmitate has been granted to Janssen Pharmaceuticals.
Invega Hafyera is a long-acting atypical antipsychotic that is administered as a gluteal intramuscular injection by a health care professional. 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 of Invega Hafyera is based on the results of a 12-month, randomized, 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 Hafyera 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 Hafyera and 95 percent treated with Invega Trinza were relapse-free at 12 months.1 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.1 The most common adverse reactions (≥5%) in the Invega Hafyera clinical trial were upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).
"Before I found the right treatment plan for me, my symptoms often got in the way of things that I loved to do," said Patrick, an adult living with schizophrenia and a participant in the clinical trial. "But since my doctor introduced me to Janssen's long-acting injectable options and my symptoms are controlled, I have the clarity to focus on the present, but also the stability to plan for my future."
Schizophrenia is a complex and chronic brain disorder in which the symptoms and potential for relapse (or recurrence of symptoms) can impact many aspects of a person's daily life. On average, an adult with schizophrenia experiences nine relapses in less than six years, often due to missed doses of medication. Adults living with schizophrenia and their loved ones face ongoing functional, emotional, and financial burdens. In addition, patients who experience more relapses may have more hospitalizations, which can lead to higher medical costs for patients, hospital systems, and payers.
"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."
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.
Invega Hafyera is a long-acting injectable treatment that is administered by a healthcare provider in the upper buttocks area every six months. Invega Hafyera dissolves slowly into the bloodstream after injection, resulting in continuous treatment and symptom control over six months.
"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 lifeless defined by schizophrenia medication."
The Janssen U.S. portfolio of long-acting injectable treatments for adults with schizophrenia provides the most varied range of dosing options and the longest-lasting schizophrenia treatments available. Our portfolio includes RISPERDAL CONSTA® (risperidone), Invega Sustenna (1-month paliperidone palmitate), Invega Trinza (3-month paliperidone palmitate),8 and Invega Hafyera (6-month paliperidone palmitate),1 all of which are administered in a clinical setting by a medical professional.
"The approval of Invega Hafyera builds on our 60-year legacy of delivering transformational medicines for adults living with schizophrenia," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "This approval further underscores our steadfast commitment to addressing critical unmet needs, including treatment adherence concerns, faced by adults living with schizophrenia."