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Janssen, Receives

Janssen Receives Positive CHMP Opinion for BYANNLI® for the Maintenance Treatment of Schizophrenia in Adults

17.09.2021 - 12:52:33

Janssen Receives Positive CHMP Opinion for BYANNLI® for the Maintenance Treatment of Schizophrenia in Adults. The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the long-acting atypical antipsychotic therapy BYANNLI® (6-monthly paliperidone palmitate; PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1-monthly paliperidone palmitate (PP1M)2 or 3-monthly paliperidone palmitate (PP3M).3 If approved by the European Commission, PP6M will provide the first twice-yearly treatment for adults living with schizophrenia and longest available dosing interval for an antipsychotic medication in the European Economic Area.1,4

or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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*Professor Silvana Galderisi has been a paid consultant for Janssen. She has not been compensated for any media work.


Data on file. PP6M. Protocol R092670PSY3015: Phase 3 objectives, methods, primary efficacy results, adverse events. September 2021. Document number: RF-185391.European Medicines Agency. Xeplion Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/xeplion-epar-product-information_en.pdf. Accessed September 2021.European Medicines Agency. Trevicta Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/trevicta-epar-product-information_en.pdf. Accessed September 2021.Johnson & Johnson Ltd. Press release on November 2020. Available at: https://www.prnewswire.com/news-releases/janssen-submits-paliperidone-palmitate-6-month-pp6m-supplemental-new-drug-application-to-us-fda-for-treatment-of-schizophrenia-in-adults-301164580.html. Accessed September 2021.Clinicaltrialsregister.eu. A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6 Month Formulation. Identifier: 2017-001941-28. Available at https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-001941-28/ES. Accessed September 2021.Clinicaltrials.gov. A Study of Paliperidone Palmitate 6-Month Formulation. Identifier: NCT03345342. Available at: https://clinicaltrials.gov/ct2/show/NCT03345342. Accessed September 2021.National Alliance on Mental Illness. Long-Acting Injectables. Available at: https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Long-Acting-Injectables. Accessed September 2021.Brissos S, et al. The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Ther Adv Pyschopharmacol. 2014 Oct; 4(5):198–219.World Health Organization. Schizophrenia. Available at: https://www.who.int/news-room/fact-sheets/detail/schizophrenia. Accessed September 2021.Athanasopoulou C, et al. An analysis of online health information on schizophrenia or related conditions: a cross-sectional survey. BMC Med Inform Decis Mak. 2013; 13:98.Higashi K, et al. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systemic literature review. Ther Adv Psychopharmacol. 2013 Aug; 3(4):200–18.Weiden PJ, et al. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004 Aug; 55(8):886–91.

September 2021

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