Janssen Collaborates to Further Evaluate SIRTURO® (bedaquiline) in New Multidrug-Resistant Tuberculosis Treatment Regimens
HIGH WYCOMBE, England, Nov. 6, 2014 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced a collaboration with the International Union Against Tuberculosis and Lung Disease (The Union) to include SIRTURO® (bedaquiline) in the STREAM Study. The STREAM study is an ongoing, multi-centre international randomized controlled trial to evaluate a standardized treatment regimen of anti-tuberculosis drugs for patients with MDR-TB.[i]
Bedaquiline is a diarylquinoline antimycobacterial drug, developed in the laboratories of Janssen, indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. It is the first new specific treatment for TB launched in several decades, and has a unique mechanism of action that inhibits mycobacterial ATP (adenosine 5'triphosphate) synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis.
Janssen is working with The Union, the sponsor of the study, and the study's principal investigators from the UK Medical Research Council (MRC) on an amendment to their current protocol to include two bedaquiline-containing treatment arms to further assess safety and efficacy in adult patients with pulmonary MDR-TB and also to evaluate a new treatment regimen, including an all-oral option. The amendment, which will include the two bedaquiline-containing treatment arms, will be known as 'STREAM Stage 2.' 'STREAM Stage 2' is part of the post-approval requirements for bedaquiline from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and is accepted by both health authorities as an alternative to the initially planned Phase 3 trial of SIRTURO®.
The EU prescribing information for bedaquiline includes a black triangle meaning it is subject to additional monitoring. The 'Warnings and Precautions' section in the Prescribing Information provides information regarding increased risk of mortality, occurrence of QT prolongation, risk of hepatic-related adverse drug reactions, drug interactions, use in HIV-TB co-infected patients, and use in patients with lactose intolerance and lactase deficiency. The most common adverse drug reactions seen in clinical trials were nausea, arthralgia, headache, vomiting and dizziness. Please see the full Prescribing Information and Medication Guide below for more details.
STREAM opened for recruitment in July 2012, with 'Stage 1' results expected in 2017. Details of the 'STREAM Stage 2' study protocol, which will include bedaquiline, are being finalized. The study sponsors are eager to begin 'STREAM Stage 2' and plan to begin immediately after all requisite approvals are in place. The Union, through a grant from The United States Agency for International Development (USAID), is currently funding the STREAM study.
To date, bedaquiline has received accelerated approval in the U.S., conditional approval in the European Union, approval in South Korea, South Africa and the Philippines, and is registered in the Russian Federation through a partner for the Russian Federation and CIS countries, JSC Pharmstandard. Regulatory filings have been submitted in China, Colombia, India, Peru, Thailand and Vietnam. Janssen is prioritizing registration in high MDR-TB burden countries to facilitate access to bedaquiline as soon as possible.
Therapeutic indications
- Please see full Prescribing Information and Medication Guide for more details.
About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
About Janssen Global Public Health
The Janssen Global Public Health (Janssen GPH) group complements the groundbreaking science of the Janssen Pharmaceutical companies of Johnson & Johnson with innovative strategies that improve access to medicines, foster collaborations, and support public health solutions to sustainably advance health care worldwide. Current areas of focus include multidrug-resistant tuberculosis (MDR-TB); human immunodeficiency virus (HIV); elephantiasis and river blindness; intestinal worms; and use of mobile technologies (mHealth) to improve health outcomes. Through ongoing studies in TB, the Janssen GPH group aims to contribute to the goal, shared with the community, of addressing the significant unmet need for new, simplified treatment options to facilitate programmatic scale-up of MDR-TB.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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 Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, challenges inherent in new product development, including obtaining regulatory approvals. A further list and description 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 December 29, 2013, including in Exhibit 99 thereto, 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 statements as a result of new information or future events or developments.)
[i] Nunn AJ, Rusen ID, Deun AV, et al. Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial. Trials. 2014;15:353.
PHGB/BED/1014/0003
October 2014
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