Welcome!

News Feed Item

SIRTURO® (bedaquiline) Receives Conditional Approval in the European Union for the Treatment of Multi-Drug Resistant Tuberculosis

BEERSE, Belgium, March 6, 2014 /PRNewswire/ --

- For medical trade media only

Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has granted conditional approval to SIRTURO® (bedaquiline) in the European Union, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients, when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/65014-sirturo-treatment-multi-drug-resistant-tuberculosis

The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of bedaquiline on December 20, 2013.

"We are delighted that SIRTURO® has been approved for use in the European Union, as it represents a significant step forward in helping address a very serious global public health issue," said Wim Parys, Head R&D, Global Public Health at Janssen. "We will continue to work with partners and relevant authorities to ensure SIRTURO® is used correctly and appropriately, and we recognise the importance of educational efforts in informing physicians and patients about appropriate use."

SIRTURO® was discovered by scientists at Janssen 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. The conditional approval by the EC is supported by 24-week data from the Phase 2 clinical development programme, which included a controlled, randomised trial that evaluated the safety and efficacy of SIRTURO® versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen (TMC207-C208) and an open-label study (C209). The durability of effect was supported by 120-week data from the Phase 2 controlled, randomised trial.[1]

In Phase 2 studies, the SIRTURO® treatment group had a decreased time to culture conversion and improved culture conversion rates compared to the placebo treatment group. The median time to culture conversion was 83 days for the SIRTURO® treatment group, compared to 125 days for the placebo treatment group at week 24 (TMC207-C208). At week 120, treatment with SIRTURO® continued to result in a significantly improved culture conversion rate versus the placebo treatment group.

Furthermore, based on WHO-recommended treatment outcome definitions applied to week 120 final data, the proportion of patients defined as cured at 120 weeks was 57.6% in the SIRTURO® arm vs. 31.8% in the placebo arm (p=0.003).[2]

"MDR-TB is associated with a high mortality rate and poses a significant public-health threat, as individuals infected with drug-resistant strains are often unable to receive adequate treatment and can potentially spread their infection," said Professor Martin Grobusch, Head of the Center for Tropical Medicine and Travel Medicine, University of Amsterdam. "Today's approval is a critical step forward in tackling this rapidly growing disease and speeding up patient access to much needed treatment."

Under the provisions of the conditional approval, Janssen commits to support a Phase 3 study to further substantiate the benefit-risk for SIRTURO® and define its optimal use, with regards to the number and types of agents that are needed in combination, and its optimal treatment duration.

To date, SIRTURO® has received accelerated approval in the United States and has been registered in the Russian Federation by JSC Pharmstandard, the company Janssen signed a license agreement with in 2013 for Russia and the Commonwealth of Independent States. Regulatory filings have also been submitted in South Africa, China, India, Thailand, Vietnam, Colombia, and South Korea.

About Multi-Drug Resistant Tuberculosis (MDR-TB)

MDR-TB is a particularly complicated form of TB characterised by resistance to at least two of the standard four-drug, anti-TB drugs.[3] Inadequately treated patients are likely to increase selective pressure, allowing resistant bacteria to thrive and pose a significant transmission risk to the general population.[4] Without significant public health intervention, MDR-TB is projected to infect more than two million people between 2011 and 2015.[4]

About The Clinical Development Program

The clinical development program includes two Phase 2 studies in patients with MDR-TB. TMC207-C208 was conducted in two independent stages: Stage 1 was a controlled, randomised, exploratory trial and Stage 2 was a controlled, randomised superiority trial in MDR-TB patients. Stage 2 compared time to culture conversion following the use of SIRTURO® (400 mg once daily for two weeks followed by 200 mg three times a week for 22 weeks) versus placebo in combination with a standardised background regimen for MDR-TB. The study enrolled 161 patients who received treatment for 24 weeks followed by continuation of the background therapy for an additional 12 to 18 months. Results were presented in 2010 at the 41st Union World Conference on Lung Health in Berlin, Germany.[5] Results from Stage 1 were published in The New England Journal of Medicine[6] in 2009. The submission contains 120 week data from TMC207-C208 Stage 2, the results of which were published in 2013 at the 44th Union World Conference of Lung Health in Paris, France.[1]  

TMC207-C209 is a Phase 2 open-label trial in MDR-TB patients, in which SIRTURO® was administered as 400 mg once daily for two weeks followed by 200 mg three times weekly for 22 weeks in combination with an individualised background regimen for MDR-TB, followed by continued administration of the background regimen for 12 to 18 months. A total of 233 patients from 11 countries were enrolled in the trial, designed to evaluate the safety and efficacy of SIRTURO® in treatment-experienced patients, including 25% with pre-extensively drug-resistant TB (pre-XDR) and 21% with XDR-TB.  Results were presented in 2011 at the 42nd Union World Conference on Lung Health in Lille, France.[7]  

Janssen will conduct a Phase 3 study to further substantiate the benefit-risk for SIRTURO® and define the optimal use of SIRTURO®, with regards to the number and types of agents that are needed in combination, and the optimal treatment duration.

About Janssen Global Public Health

Janssen Global Public Health (Janssen GPH) 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 focus includes multi-drug resistant tuberculosis (MDR-TB); human immunodeficiency virus (HIV); elephantiasis and river blindness; intestinal worms; and use of mobile technologies (mHealth) to improve health outcomes.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Infectious Diseases-Diagnostics BVBA, any of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. 

Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. 

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 our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at   http://www.sec.gov http://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.)

References

1. Diacon A, Pym A, Grobusch M, et al. Final 120-week results of a Phase II randomised, double-blind, placebo-controlled study of 24-weeks bedaquiline treatment for MDR-TB (C208). Int J Tuberc Lung Dis 2013;17(Suppl 2):S234-5 (abstract OP-176-02).

2. WHO. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis, Interim Policy Guidance. 2013. Available at: http://apps.who.int/iris/bitstream/10665/84879/1/9789241505482_eng.pdf . Accessed 07 February, 2014.

3. WHO. Multidrug-Resistant Tuberculosis, Online Q&A. February 2012. Available at http://www.who.int/features/qa/79/en/index.html. Accessed January 29, 2014.

4. WHO. Partners call for increased commitment to tackle MDR-TB. 23 March 2011. Available at http://www.who.int/mediacentre/news/releases/2011/TBday_20110322/en/index.html. Accessed January 29, 2014.

5. McNeeley DF. Diacon H, Pym A, et al. TMC-207 versus placebo plus OBT for the treatment of MDR-TB: a prospective clinical trial. Oral presentation at the 41st Union World Conference on Lung Health; November 11-15, 2010; Berlin, Germany, http://uwclh.conference2web.com/content/all#/?search=mcneeley&sessions=35

6. Diacon AH, Pym A, Grobusch M, et al. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med 2009;360:2397-405.

7. Pym A, Dicon A. Conradie F, et al. Bedaquiline as part of a multidrug-resistant tuberculosis therapy regimen: interim and final results of a single-arm, phase II trial (C209). Int J Tuberc Lung Dis 2013;17(Suppl 2):S236 (abstract OP-179-02).

 


Video: http://www.multivu.com/mnr/65014-sirturo-treatment-multi-drug-resistant-tuberculosis

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Infoblox delivers Actionable Network Intelligence to enterprise, government, and service provider customers around the world. They are the industry leader in DNS, DHCP, and IP address management, the category known as DDI. We empower thousands of organizations to control and secure their networks from the core-enabling them to increase efficiency and visibility, improve customer service, and meet compliance requirements.
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, will describe how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launchi...
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant tha...
Transforming cloud-based data into a reportable format can be a very expensive, time-intensive and complex operation. As a SaaS platform with more than 30 million global users, Cornerstone OnDemand’s challenge was to create a scalable solution that would improve the time it took customers to access their user data. Our Real-Time Data Warehouse (RTDW) process vastly reduced data time-to-availability from 24 hours to just 10 minutes. In his session at 21st Cloud Expo, Mark Goldin, Chief Technolo...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, will lead you through the exciting evolution of the cloud. He'll look at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering ...
Cloud Expo, Inc. has announced today that Andi Mann and Aruna Ravichandran have been named Co-Chairs of @DevOpsSummit at Cloud Expo Silicon Valley which will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. "DevOps is at the intersection of technology and business-optimizing tools, organizations and processes to bring measurable improvements in productivity and profitability," said Aruna Ravichandran, vice president, DevOps product and solutions marketing...
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, will discuss how from store operations...
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
The session is centered around the tracing of systems on cloud using technologies like ebpf. The goal is to talk about what this technology is all about and what purpose it serves. In his session at 21st Cloud Expo, Shashank Jain, Development Architect at SAP, will touch upon concepts of observability in the cloud and also some of the challenges we have. Generally most cloud-based monitoring tools capture details at a very granular level. To troubleshoot problems this might not be good enough.
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
We all know that end users experience the Internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices – not doing so will be a path to eventual b...
In the fast-paced advances and popularity in cloud technology, one of the most critical factors revolves around concerns for security of your critical data. How to assure both your company and your customers they can confidently trust and utilize your cloud environment is most often top on the list. There is a method to evaluating and providing security that exceeds conventional modes of protecting data both within the cloud as well externally on mobile and other devices. With the public failure...
Recently, REAN Cloud built a digital concierge for a North Carolina hospital that had observed that most patient call button questions were repetitive. In addition, the paper-based process used to measure patient health metrics was laborious, not in real-time and sometimes error-prone. In their session at 21st Cloud Expo, Sean Finnerty, Executive Director, Practice Lead, Health Care & Life Science at REAN Cloud, and Dr. S.P.T. Krishnan, Principal Architect at REAN Cloud, will discuss how they b...
SYS-CON Events announced today that mruby Forum will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. mruby is the lightweight implementation of the Ruby language. We introduce mruby and the mruby IoT framework that enhances development productivity. For more information, visit http://forum.mruby.org/.