Janssen Announces China Approval of INVEGA HAFYERA® (Paliperidone Palmitate Injection [6M]), the First and Only Twice-Yearly Long-Acting Injectable for Adults with Schizophrenia

Jun 24, 2024 18:43 CST Updated 18:43

Johnson & Johnson

Medical Device R&D and Manufacturer

Johnson & Johnson announced today that its long-acting injection administered once every six monthsShan Jiu Da® (Paliperidone Palmitate Injection (6M), INVEGA HAFYERA®, English generic name: Paliperidone Palmitate Injection (6M)) has recently been granted marketing authorization approval by the National Medical Products Administration for use in adult patients with schizophrenia who have received at least 3 months of adequate treatment with Paliperidone Palmitate Injection (3M).^[1]。

As a new member of the Johnson & Johnson long-acting injectable family,Shan Jiu Da®Is currently the first and only long-acting injectable antipsychotic drug approved in China that requires only two injections per year.^[2], achieving continuous treatment and symptom control for up to six months by slowly releasing into the bloodstream at the injection site.^[^3]. In existing products (Invega Sustenna with one injection per month)®And Sustenna, administered once every three months®) Based on the actual medication needs of schizophrenia patients, Johnson & Johnson continuously optimizes its products to provide long-term, stable, and upgradable treatment solutions for the entire course of treatment and management of schizophrenia.

Schizophrenia is a serious mental illness caused by the interaction of genetic, biological, and environmental factors, often accompanied by disorders in perception, thinking, emotion, and behavior.^[4]Due to its long course, severe condition, and susceptibility to recurrence, schizophrenia imposes a significant disease burden on patients, families, and society.^[3]Relevant studies show that the relapse rate of Chinese schizophrenia patients within one year after discharge is as high as 33.4%.^[5], and interruption of medication or self-reduction of dosage is an important reason for disease recurrence.^[5]。

Compared with oral medications,Long-acting injections offer many advantages in the treatment of schizophrenia, including improved patient compliance, eliminating the need for repeated medication reminders, greater convenience, and reduced risk of accidental or overdose medication.^[6]Long-acting injections with longer dosing intervals can better support disease management and help patients achieve the ultimate goal of returning to family and society.^[7][8]。

"This time, Johnson & Johnson®"The approval once again demonstrates Johnson & Johnson's continuous care for Chinese patients over the past thirty-nine years. As an innovative leader in the field of mental health, we deeply understand the importance of innovative drugs such as long-acting injections to patients, and we will continue to optimize our product line to offer more choices to patients." Cherry Huang, President of Johnson & Johnson Innovative Pharmaceuticals China, stated, "In the future, we will closely collaborate with the government and relevant institutions to introduce Silexan as soon as possible."®"This revolutionary treatment solution ensures that our breakthrough achievements can help more patients return to normal life."

Support this Shan Jiuda®A randomized, double-blind, non-inferiority global Phase 3 clinical study approved for marketing authorization^[2]Data shows that at the end of 12 months, DePuy Synthes®In the aspect of preventing disease recurrence with Xiantuoda®Compared to having non-inferiority (i.e., with Xiantuoda®(With considerable therapeutic effects). At the same time, the open-label extension study conducted on the basis of this research^[9]The results suggest that 96.1% of schizophrenia patients accept Johnson & Johnson's treatment.®No recurrence after 2 years of treatment.

References:

[1] Instructions for Paliperidone Palmitate Injection (6M), June 2024.

[2] Center for Drug Evaluation, National Medical Products Administration. Directory of Chemical Drugs, May 14, 2024. https://www.cde.org.cn

[3] Najarian D, et al. A randomized, double-blind, multicenter, noninferiority study comparing Paliperidone Palmitate 6-month versus the 3-month long-acting injectable in patients with schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251.

[4] National Health Commission of the People's Republic of China. Diagnostic and Treatment Standards for Mental Disorders. 2020. P115.

[5] Xiao J, Mi W, Li L, Shi Y, Zhang H. High relapse rate and poor medication adherence in the Chinese population with schizophrenia: results from an observational survey in the People's Republic of China. Neuropsychiatr Dis Treat. 2015 May 8. 11:1161-7.

[6] Brissos S, Veguilla MR, Taylor D, et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Therapeutic Advances in Psychopharmacology. 2014. 4(5):198-219.

[7] Garcia-Portilla MP, et al. Impact on functionality of the paliperidone palmitate three-month formulation in patients with a recent diagnosis of schizophrenia: a real-world observational prespective study. Expert OpinPharmacother. 2022 Jan. 5:1-10.

[8] PungorK, et al. The Patient, Investigator, Nurse, Carer Questionnaire (PINC-Q): a cross-sectional, retrospective, non-interventional study exploring the impact of less frequent medication administration with paliperidone palmitate 3-monthly as maintenance treatment for schizophrenia. BMC Psychiatry 2021 Jun. 21:300.

[9] Najarian D, et al. Long-term efficacy and safety of Paliperidone 6-month formulation: An open-lable 2-year extension of a 1-year double-blind study in adult participants with schizophrenia. Int J Neuropsychopharmacol. 2023 Jul 22. 26:537-544.