Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia

INVEGA HAFYERA™ offers patients the fewest doses per year for a life less defined by schizophrenia medication

Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months

Approval is backed by nearly two decades of proven efficacy and safety of Janssen's long-acting injectable portfolio of schizophrenia medicines

TITUSVILLE, NJ, USA I September 1, 2021 I The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (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.1

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 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 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%).1

Click-to-Tweet: #BREAKINGNEWS the @US_FDA approved new long-acting injectable treatment with fewer doses a year for adult patients living with #schizophrenia. Click here to learn more: https://bit.ly/3gDSI3j

"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."

Click-to-Tweet: Patrick, an adult living with schizophrenia, talks about his treatment journey and how a long-acting injectable has helped him stay on track with his goals: https://bit.ly/3gDSI3j

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.2 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.3,4,5 

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.1 

"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."

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),6 INVEGA SUSTENNA® (1-month paliperidone palmitate),7 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."

Janssen CarePath offers a comprehensive support program that helps patients get started on INVEGA HAFYERA™ 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.

*Dr. Alva has received research support from Janssen and has served as a paid consultant to the Company.

Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA™.

INDICATION
INVEGA HAFYERA™ is a prescription medicine given by injection by a healthcare provider 1 time every 6 months and used for the treatment of schizophrenia in adults who have been adequately treated with either:

  • A 1-time-each-month paliperidone palmitate extended-release injectable suspension for at least 4 months
  • A 1-time-every-3-months paliperidone palmitate extended-release injectable suspension for at least 3 months

About the Clinical Trial

The approval of INVEGA HAFYERA™ is based on the results of a randomized, double-blind, non-inferiority Phase 3 global study that enrolled 702 adults (ages 18-70) living with schizophrenia, designed to demonstrate that injection of INVEGA HAFYERA™ is not less effective than INVEGA TRINZA® in delaying time to first relapse in participants previously stabilized on corresponding doses of INVEGA SUSTENNA® or INVEGA TRINZA®.1 Data showed non-inferiority of INVEGA HAFYERA™ compared to INVEGA TRINZA® on the primary endpoint of time to first relapse at the end of the 12-month period in both intent-to-treat and per protocol analysis sets.

The study consisted of four treatment phases:

  • Screening phase (up to 28 days)
  • Transition phase (1 to 4 months), applicable to those adult patients who entered the screening phase before being stabilized on INVEGA SUSTENNA® or INVEGA TRINZA®
  • Open-label maintenance phase in which adult patients received 1 dose of INVEGA SUSTENNA® at 156 mg or 234 mg dosage or INVEGA TRINZA® at 546 mg or 819 mg dosage and remained in this phase for 1 or 3 months, accordingly
  • Double-blind phase (of 12 months), in which all 702 stabilized adult patients were randomized in a 2:1 ratio to receive INVEGA HAFYERA™ (478 patients) or INVEGA TRINZA® (224 patients).1 Study evaluations included efficacy, safety, pharmacokinetics, and pharmacodynamics

The study's duration, from screening to double-blind endpoint, varied from approximately 13 months to 19 months depending on treatment arm.1

About Long-Acting Injectables

Long-acting injectables (LAIs) allow for the slow release of medicine into the bloodstream and have been available and studied for more than 50 years.9 LAI antipsychotics offer a number of potential advantages compared to oral medication, including not having to remember to take medicine daily, improved patient outcomes, improved patient and physician satisfaction, and lower relapse rates.10 Based on clinical guidance, the National Council for Mental Wellbeing and the American Psychiatric Association recently updated their guidance and practice guidelines to recommend the use of LAIs for appropriate patients.3,4,5

About Schizophrenia

Schizophrenia is a chronic and severe brain disorder affecting approximately 20 million people worldwide11 and an estimated 2.8 million adults in the U.S.12,13 The disease is characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior.11 It can also lead to neurological impairment and severe disability.14

Antipsychotic medication is recognized as an essential component in the treatment of schizophrenia, and adherence to medication plays a critical role in controlling symptoms and costly relapses.15

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

References

  1. INVEGA HAFYERA™ [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. August 2021.
  2. Lafeuille MH, Gravel J, Lefebvre P, et al. Patterns of relapse and associated cost burden in schizophrenia patients receiving atypical antipsychotics. J Med Econ. 2013;16(11):1290-1299. doi: 10.3111/13696998.2013.841705
  3. The American Psychiatric Association. Practice Guideline for the Treatment of Patients with Schizophrenia. 3rd ed. Arlington, VA. American Psychiatric Publishing. 2020. Accessed July, 21, 2021. Available at: https://psychiatryonline.org/doi/pdf/10.1176/appi.books.9780890424841
  4. American Psychiatric Association. APA Releases New Practice Guideline on Treatment of Patients with Schizophrenia. American Psychiatric Association website. 2020. Accessed July 21, 2021. Available at: https://www.psychiatry.org/newsroom/news-releases/apa-releases-new-practice-guideline-on-treatment-of-patients-with-schizophrenia
  5. National Council for Mental Wellbeing. Guide to Long-Acting Medications. National Council for Mental Wellbeing website. Accessed July 21, 2021. Available at: https://www.thenationalcouncil.org/topics/long-acting-medications/
  6. RISPERDAL CONSTA®. Important Safety Information. Accessed February 2021. Available at: https://www.janssencarepath.com/hcp/risperdal-consta
  7. INVEGA SUSTENNA®. Important Safety Information. Accessed August 2021.Available at:  https://www.invegasustenna.com/important-safety-information
  8. INVEGA TRINZA®. Important Safety Information. Accessed August 2021. Available at: https://www.invegatrinzahcp.com/side-effects-safety/tolerability-adverse-reactions
  9. National Alliance on Mental Illness. Long-Acting Injectables. National Alliance on Mental Illness website. 2016. Accessed July 21, 2021. Available at: https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Long-Acting-Injectables
  10. Brissos S, Veguilla MR, Taylor D, et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Ther Adv Psychopharmacology. 2014;4(5):198-219. doi:10.1177/2045125314540297
  11. World Health Organization. Schizophrenia. World Health Organization website. 2019. Accessed July 21, 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/schizophrenia
  12. Regier DA, Farmer ME, Rae DS, et al. One–month prevalence of mental disorders in the United States and sociodemographic characteristics: the epidemiologic catchment area study. Acta Psychiatr Scand. 1993;88(1):35-47. doi:10.1111/j.1600-0447.1993.tb03411.x
  13. US Census Bureau. 2010 US Census. Accessed July 21, 2021. Available at: https://www.census.gov/topics/population/data.html
  14. Andreasen N, Nopoulos P, Magnotta V et al. Progressive brain change in schizophrenia: a prospective longitudinal study of first-episode schizophrenia. Biol Psychiatry. 2011;70(7):672-679. doi:10.1016/j.biopsych.2011.05.017
  15. Higashi K, Medic G, Littlewood K, et al. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systemic literature review. Ther Adv Psychopharmacol. 2013;3(4):200-218. doi:10.1177/2045125312474019

SOURCE: Janssen Pharmaceutical Companies of Johnson & Johnson

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