Janssen Announces U.S. FDA Approval of INVEGA HAFYERA? (6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia
TITUSVILLE, N.J.,?Sept. 1, 2021?/PRNewswire/ --?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:
Medicines are sometimes prescribed for purposes other than those listed. You can ask your pharmacist or healthcare provider for information about INVEGA HAFYERA? that is written for health professionals. Please?click here??to read the full Prescribing Information, including Boxed WARNING, for
INVEGA?HAFYERA??and discuss any questions you have with your healthcare professional. 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:
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
- Increased risk of death in elderly people with dementia-related psychosis.
INVEGA HAFYERA? increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). INVEGA HAFYERA? is not for the treatment of people with dementia-related psychosis.
- have had Neuroleptic Malignant Syndrome (NMS)
- have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
- have or have had low levels of potassium or magnesium in your blood
- have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
- have or have had kidney or liver problems
- have diabetes or have a family history of diabetes
- have Parkinson's disease or a type of dementia called Lewy Body Dementia
- have had a low white blood cell count
- have had problems with dizziness or fainting or are being treated for high blood pressure
- have or have had seizures or epilepsy
- are pregnant or plan to become pregnant. It is not known if INVEGA HAFYERA? will harm your unborn baby.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with INVEGA HAFYERA?.
- If you become pregnant while receiving INVEGA HAFYERA?, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit?http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
- Babies born to mothers who receive INVEGA HAFYERA? during their third trimester of pregnancy may develop agitation, low muscle tone (floppy baby syndrome), tremors, excessive sleepiness, breathing problems, and feeding problems. Tell your healthcare provider right away if your baby develops any of these symptoms.
- are breastfeeding or plan to breastfeed. INVEGA HAFYERA? can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with
INVEGA HAFYERA?.
- Follow your INVEGA HAFYERA? treatment schedule exactly as your healthcare provider tells you to.
- Your healthcare provider will tell you how much INVEGA HAFYERA? you will receive and when you will receive it.
- INVEGA HAFYERA? is given as an injection by your healthcare provider into the muscle (intramuscularly) of your buttocks, 1 time every 6?months.
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how
INVEGA HAFYERA? affects you. INVEGA HAFYERA? may affect your judgment, thinking, or motor skills. - Avoid getting too hot or dehydrated.
- Do not exercise too much.
- In hot weather, stay inside in a cool place if possible.
- Stay out of the sun.
- Do not wear too much clothing or heavy clothing.
- Drink plenty of water.
- See?"What is the most important information I should know about?INVEGA HAFYERA??"
- Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
- Neuroleptic Malignant Syndrome (NMS), a serious condition that can lead to death.?Call your healthcare provider or go to your nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
- high fever
- confusion
- changes in your breathing, pulse, heart rate, and blood pressure
- stiff muscles
- sweating
- Problems with your heartbeat.?These heart problems can cause death. Call your healthcare provider right away if you have any of these symptoms:
- passing out or feeling like you will pass out
- dizziness
- feeling as if your heart is pounding or missing beats
- Uncontrolled body movements (tardive dyskinesia).?INVEGA HAFYERA? may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving INVEGA HAFYERA?. Tardive dyskinesia may also start after you stop receiving INVEGA HAFYERA?.
- Problems with your metabolism such as:
- high blood sugar (hyperglycemia) and diabetes.?Increases in blood sugar can happen in some people who receive INVEGA HAFYERA?. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start and regularly during treatment with INVEGA HAFYERA?.
Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with INVEGA HAFYERA?:- feel very thirsty
- feel very hungry
- feel sick to your stomach
- need to urinate more than usual
- feel weak or tired
- feel confused, or your breath smells fruity
- increased fat levels (cholesterol and triglycerides) in your blood.?Your healthcare provider should check the fat levels in your blood before you start and regularly during treatment with INVEGA HAFYERA?.
- weight gain.?You and your healthcare provider should check your weight before you start and often during treatment with INVEGA HAFYERA?.
- high blood sugar (hyperglycemia) and diabetes.?Increases in blood sugar can happen in some people who receive INVEGA HAFYERA?. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start and regularly during treatment with INVEGA HAFYERA?.
- Decreased blood pressure (orthostatic hypotension) and fainting.?You may feel lightheaded or faint when you rise too quickly from a sitting or lying position, especially early in treatment or when the dose is changed.
- Falls.?INVEGA HAFYERA? may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
- Low white blood cell count.?Your healthcare provider may do blood tests during the first few months of treatment with INVEGA HAFYERA?.
- Increased prolactin levels in your blood (hyperprolactinemia).?INVEGA HAFYERA? may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, a reversible reduction in fertility in females who are able to become pregnant, leakage of milk from the breasts, development of breasts in men, or problems with erection.
- INVEGA HAFYERA??can make you sleepy or dizzy, and can slow your thinking and motor skills.?Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA? affects you.
- Seizures (convulsions).
- Difficulty swallowing?that can cause food or liquid to get into your lungs.
- Prolonged or painful erection lasting more than 4 hours (priapism).?Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours.
- Problems controlling your body temperature so that you feel too warm.?See, "What should I avoid while receiving INVEGA HAFYERA??"
- upper respiratory tract infections
- weight gain
- feeling restlessness or difficulty sitting still
- tremors
- shuffling walk
- injection site reactions
- headache
- slow movements
- stiffness
Medicines are sometimes prescribed for purposes other than those listed. You can ask your pharmacist or healthcare provider for information about INVEGA HAFYERA? that is written for health professionals. Please?click here??to read the full Prescribing Information, including Boxed WARNING, for
INVEGA?HAFYERA??and discuss any questions you have with your healthcare professional. 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
- INVEGA HAFYERA? [Prescribing Information].?Titusville, NJ: Janssen Pharmaceuticals, Inc.?August 2021.
- 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
- 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
- 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
- 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/
- RISPERDAL CONSTA?. Important Safety Information. Accessed February?2021. Available at:?https://www.janssencarepath.com/hcp/risperdal-consta
- INVEGA SUSTENNA?. Important Safety Information. Accessed August?2021.Available at:??https://www.invegasustenna.com/important-safety-information
- INVEGA TRINZA?. Important Safety Information. Accessed August?2021. Available at:?https://www.invegatrinzahcp.com/side-effects-safety/tolerability-adverse-reactions
- 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
- 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
- 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
- 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
- US Census Bureau. 2010 US Census. Accessed?July 21, 2021. Ava