Janssen Receives Positive CHMP Opinion for BYANNLI® (6-monthly Paliperidone Palmitate) 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
“With only two injections per year, 6-monthly paliperidone palmitate has the potential to reduce the burden of taking medication frequently, giving eligible patients the opportunity to focus on other aspects of their life,” said Ludovic de Beaucoudrey, Ph.D., EMEA Therapeutic Area Lead, Janssen-Cilag. “Today’s Positive Opinion from the CHMP underscores Janssen’s 60-year commitment to transforming the lives of people living with schizophrenia through rigorous scientific research and product development.”
The marketing authorisation application is based on the Route 6 Study, a randomised, double-blind, non-inferiority Phase 3 global study designed to demonstrate that PP6M is not less effective than PP3M for the prevention of relapse in participants previously stabilised on a shorter-acting formulation of paliperidone palmitate.1,5,6 The study enrolled 702 adults living with schizophrenia from 20 countries, including Bulgaria, Czech Republic, France, Hungary, Italy, Poland, Russia, Spain and Turkey.1,5 The results showed non-inferiority of PP6M compared with PP3M 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 PP6M and 95.1 percent treated with PP3M were relapse-free at 12 months.1 Relapse was defined as psychiatric hospitalisation, increase in Positive and Negative Syndrome Scale (PANSS) total score, increase in individual PANSS item scores, violent behaviour resulting in self-injury or suicidal/homicidal ideation.
“When it comes to the treatment of schizophrenia, unmet needs remain, including treatment adherence concerns, despite currently available therapies,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Janssen Research & Development, LLC. “The Positive Opinion received from the CHMP today, enables us to rethink how we manage this chronic disease and brings us one step closer to offering patients and caregivers the potential for a life less defined by medication.”
The safety profile observed for PP6M was consistent with previous studies of PP1M and PP3M with no new safety signals emerging.1 The most common treatment emergent adverse reactions (≥5.0 percent) in the study’s PP6M group were weight increase (8.4 percent), injection site pain (7.7 percent), headache (6.7 percent) and upper respiratory tract infection (5.0 percent). There were no unexpected serious adverse reactions.1
“Non-adherence to prescribed drug treatments has been recognised as a challenge for treatment continuity that can potentially have a negative impact on treatment outcomes,” said Professor Silvana Galderisi,* Route 6 Study Investigator and Professor of Psychiatry and Director of the Emergency Unit of the Department of Mental Health at the University of Campania Luigi Vanvitelli, Italy. “It is therefore essential to provide a variety of treatment options to meet different patient needs. If approved by the European Commission, PP6M’s extended dosing interval may help address a key unmet need within this population.”
Following this Positive CHMP Opinion, the European Commission will now consider approval of a marketing authorisation for PP6M as a long-acting injectable maintenance treatment for adults with schizophrenia who are clinically stable on 1‑monthly or 3‑monthly paliperidone palmitate injectable products. The European Commission has the authority to grant marketing authorisation for medicines in the European Economic Area.
About the Route 6 Study (PSY3015)
The Route 6 Study was a randomised, double-blind, non-inferiority global Phase 3 study of 702 adults (ages 18–70) with schizophrenia, designed to demonstrate that injection cycles consisting of a single administration of PP6M (700 or 1000 mg) are not less effective than two sequentially administered injections of PP3M (350 or 525 mg) for the prevention of relapse in subjects with schizophrenia previously stabilised on corresponding doses of PP1M (100 or 150 mg) or PP3M (350 or 525 mg).1
The study consisted of four treatment phases: a screening phase (up to 28 days); a transition phase (of 1 to 4 months), applicable to those adult patients who entered the screening phase before being stabilised on PP1M or PP3M; a maintenance phase (of 1 or 3 months), used to stabilise patients on PP1M or PP3M prior to the double-blind phase; and a double-blind phase (of 12 months).
In the double-blind phase all stabilised adult patients (N=702) were randomised in a 2:1 ratio to receive PP6M (n=478) or PP3M (n=224).1
Study evaluations included efficacy, pharmacokinetics, pharmacodynamics and safety. The study’s duration 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 a drug into the blood and have been on the market for more than 50 years.7 LAI antipsychotics have been demonstrated to offer a number of advantages compared with oral medication, including not having to remember to take drugs daily, improved patient outcomes, improved patient and physician satisfaction, and lower relapse rates.8
In 2002, a 1‑monthly injectable formulation (PP1M) was approved by the European Commission as a maintenance treatment of schizophrenia in adult patients under the brand name XEPLION®.2 In 2016, a 3-monthly LAI formulation (PP3M) was approved under the trade name TREVICTA®.3
Schizophrenia is a chronic and severe brain disorder affecting approximately 20 million people worldwide9 and an estimated 3.7 million people in the EU.10 The disease is characterised by distortions in thinking, perception, emotions, language, sense of self and behaviour leading to neurological impairment, severe disability and increased mortality.8
Antipsychotic medication is recognised as an essential component in the treatment of schizophrenia, and adherence to medication plays a critical role in preventing symptoms and relapses.11 Early intervention in schizophrenia may improve patient outcomes as more than 69 percent of people with schizophrenia do not receive appropriate care.9
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.
Janssen Pharmaceutica N.V., Janssen Research & Development, LLC. and Janssen-Cilag are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com/emea. Follow us at https://twitter.com/JanssenEMEA.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding 6-monthly paliperidone palmitate (PP6M). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceutica N.V., Janssen Research & Development, LLC., Janssen-Cilag and any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com 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.
# # #
*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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Mobile: +31 6 1526 8214
Investor Relations contact:
Office: +1 (732) 524-3922
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EnTrust Global Completes Acquisition of Maas Capital From ABN AMRO21.10.2021 14:00:00 EEST | Press release
The Blue Ocean strategy managed by EnTrust Global (“EnTrust”), a leading alternative asset management firm, announced today that it has completed the acquisition of Maas Capital Shipping B.V. from ABN AMRO. Since its inception in the late 1990s, the Maas Capital platform has deployed close to $1.0 billion in equity maritime investments and is currently one of the world’s leading institutional shipping equity investors. The acquired portfolio includes a diversified portfolio of 15 equity joint venture investments, consisting of a fleet of 76 high-quality vessels within the product/chemical tanker, dry bulk, LPG, container, and offshore services segments. In addition, the portfolio includes an equity stake in a growing intermodal business which leases out container boxes. The acquisition is the latest expansion of EnTrust’s maritime finance strategy, Blue Ocean, which is part of the firm’s broader maritime-focused Blue Ocean Group. As part of the transaction, EnTrust has engaged six memb
Liuzhou Steel Group Automates Bulk Material Handling with 3D LiDAR Solution from Quanergy21.10.2021 13:00:00 EEST | Press release
Quanergy Systems, Inc., a leading provider of OPA-based solid state LiDAR sensors and smart 3D solutions for automotive and IoT, today announced its latest achievement in industrial automation with the deployment of its 3D LiDAR solutions for heavy machinery operation in China. Collaborating with Hunan Qiaokang Bridge Health Intelligent Technology and Liuzhou Bierte Industrial Intelligent Technology, the solution provides highly accurate 3D modeling of bulk material piles to enable safe, efficient operation of heavy machinery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005049/en/ Liuzhou Steel Group Automates Bulk Material Handling with 3D LiDAR Solution from Quanergy (Graphic: Business Wire) Deployed at the Liuzhou Steel Group in Liuzhou City, Guangxi Province, China, Quanergy’s M-Series LiDAR sensors provide accurate, real-time 3D modeling of bulk material piles to guide and position a heavy bulk wheel piling and
Croma-Pharma Expands Successful Mask Range With Face Masks for Different Areas of Application21.10.2021 12:38:00 EEST | Press release
Croma-Pharma (Croma) announced today the expansion of its successful mask portfolio. The carefully selected ingredients of each formulation, as well as the sheet material, are tailored to specific application areas and skin needs. The products have a pleasant texture and are suitable for all skin types. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005468/en/ @Croma (Photo: Business Wire) The right mask for every need The Croma mask portfolio offers two full face masks, as well as masks for specific areas of the face including the eyes, lips, and laugh lines. Calming face mask with aloe vera, green tea and rosehip oil The Croma calming face mask contains ingredients known for their antioxidant and soothing effects, as well as skin-regenerating properties. It replenishes the skin with vitamins and helps to protect against harmful environmental influences. Regular use may help to strengthen the skin barrier and provides
DentalMonitoring, the Leading AI-Based Dental Software Company, Announces a $150 Million Growth Financing, Reaching a Valuation Over $1 Billion21.10.2021 12:22:00 EEST | Press release
DentalMonitoring has become the first dental software company to attain a valuation over $1 billion announcing a $150 million growth financing. The round is led by a new investment of $90 million from Mérieux Equity Partners and $60 million from Vitruvian Partners, an existing financial investor, demonstrating confidence in the company’s ambitious plans. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005463/en/ DentalMonitoring Since CEO and co-founder Philippe Salah launched the company in 2014, DentalMonitoring has become the first player to harness AI for remote monitoring in the dental and orthodontic fields. Driven by the treating doctor, DentalMonitoring’s AI automates messages and instructions sent to patients and practice staff to synchronize the delivery of care with the need of care. DentalMonitoring is also the first and only company offering virtual practice solutions for all dental professionals to help st
RIDDLE&CODE and Blockdaemon Join Forces to Unlock Next-Gen Industrial Tokenization Services21.10.2021 11:15:00 EEST | Press release
Leading European blockchain interface company RIDDLE&CODE and the largest crypto infrastructure platform for node management and staking Blockdaemon, announced today a strategic, long-term partnership that will focus on delivering next-gen industrial tokenization services. RIDDLE&CODE will integrate Blockdaemon's premium full node services to scale and enhance the tokenization capabilities of its Token Management Platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005053/en/ Tokenization is potentially the largest use case of blockchain that unlocks illiquid assets, simplifies their transfer and enables companies to expand and diversify portfolios. With a value that could exceed $24 trillion by 2027, it offers a range of benefits, including the development of new business models such as fractional ownership, sale and purchase of assets without middlemen, greater operational efficiency and overcoming geographic res
New Moody's ESG Solutions Tool Helps Meet EU Taxonomy Requirements21.10.2021 11:06:00 EEST | Press release
Moody’s ESG Solutions today launched EU Taxonomy Alignment Screening, a new data solution to help market participants meet the disclosure requirements of the European Union’s (EU) Taxonomy regulation. Moody’s built its tool from the ground up, an approach that sets the solution apart in this space and ensures that the underlying data is as closely aligned to the technical criteria of the EU Taxonomy as possible. "The responsible investment landscape is continually evolving due to new standards for disclosure practices and demand for ESG-labelled products,” said Sabine Lochmann, Global Head of Moody’s ESG Measures. “EU Taxonomy Alignment Screening is the latest addition to our suite of regulatory data solutions, which help market participants navigate regulatory requirements, create innovative financial products, and support efforts to build a more sustainable economy.” The EU Taxonomy provides a first-of-its-kind classification system for identifying environmentally sustainable activit
New Report from Gemserv and tado° Shows Smart Thermostats Most Cost Effective and Scalable Way to Decarbonise Homes in the EU’s Green Deal Renovation Wave21.10.2021 11:00:00 EEST | Press release
With heating and cooling of homes accounting for 21% of the EU’s energy consumption, European housing stock urgently needs decarbonising in order to lower emissions 55% by 2030 and achieve net-zero1 according to a new report from Gemserv and tado°. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005179/en/ Smart thermostats deliver over ten times as much annual carbon savings per €100 of up-front cost compared to the next best measure, an important factor in consumer decision-making. (Graphic: Business Wire) To realise these goals and reduce CO2 emissions, approximately €600 billion has been reserved in the EU’s Green Deal funds2. Decarbonisation is a huge challenge for governments across Europe, and any spending must be used as effectively and efficiently to not incur higher costs to the taxpayer. A new report produced by research consultancy Gemserv looked at the four most common methods of decarbonising homes in Euro
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom