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
Everything run by electricity will eventually be connected to the Internet. Get ahead of the Internet of Things revolution and join Akvelon expert and IoT industry leader, Sergey Grebnov, in his session at @ThingsExpo, for an educational dive into the world of managing your home, workplace and all the devices they contain with the power of machine-based AI and intelligent Bot services for a completely streamlined experience.
Because IoT devices are deployed in mission-critical environments more than ever before, it’s increasingly imperative they be truly smart. IoT sensors simply stockpiling data isn’t useful. IoT must be artificially and naturally intelligent in order to provide more value In his session at @ThingsExpo, John Crupi, Vice President and Engineering System Architect at Greenwave Systems, will discuss how IoT artificial intelligence (AI) can be carried out via edge analytics and machine learning techn...
With tough new regulations coming to Europe on data privacy in May 2018, Calligo will explain why in reality the effect is global and transforms how you consider critical data. EU GDPR fundamentally rewrites the rules for cloud, Big Data and IoT. In his session at 21st Cloud Expo, Adam Ryan, Vice President and General Manager EMEA at Calligo, will examine the regulations and provide insight on how it affects technology, challenges the established rules and will usher in new levels of diligence a...
FinTechs use the cloud to operate at the speed and scale of digital financial activity, but are often hindered by the complexity of managing security and compliance in the cloud. In his session at 20th Cloud Expo, Sesh Murthy, co-founder and CTO of Cloud Raxak, showed how proactive and automated cloud security enables FinTechs to leverage the cloud to achieve their business goals. Through business-driven cloud security, FinTechs can speed time-to-market, diminish risk and costs, maintain continu...
When shopping for a new data processing platform for IoT solutions, many development teams want to be able to test-drive options before making a choice. Yet when evaluating an IoT solution, it’s simply not feasible to do so at scale with physical devices. Building a sensor simulator is the next best choice; however, generating a realistic simulation at very high TPS with ease of configurability is a formidable challenge. When dealing with multiple application or transport protocols, you would be...
An increasing number of companies are creating products that combine data with analytical capabilities. Running interactive queries on Big Data requires complex architectures to store and query data effectively, typically involving data streams, an choosing efficient file format/database and multiple independent systems that are tied together through custom-engineered pipelines. In his session at @BigDataExpo at @ThingsExpo, Tomer Levi, a senior software engineer at Intel’s Advanced Analytics ...
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
In the enterprise today, connected IoT devices are everywhere – both inside and outside corporate environments. The need to identify, manage, control and secure a quickly growing web of connections and outside devices is making the already challenging task of security even more important, and onerous. In his session at @ThingsExpo, Rich Boyer, CISO and Chief Architect for Security at NTT i3, discussed new ways of thinking and the approaches needed to address the emerging challenges of security i...
As many know, the first generation of Cloud Management Platform (CMP) solutions were designed for managing virtual infrastructure (IaaS) and traditional applications. But that’s no longer enough to satisfy evolving and complex business requirements. In his session at 21st Cloud Expo, Scott Davis, Embotics CTO, will explore how next-generation CMPs ensure organizations can manage cloud-native and microservice-based application architectures, while also facilitating agile DevOps methodology. He wi...
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Historically, some banking activities such as trading have been relying heavily on analytics and cutting edge algorithmic tools. The coming of age of powerful data analytics solutions combined with the development of intelligent algorithms have created new opportunities for financial institutions. In his session at 20th Cloud Expo, Sebastien Meunier, Head of Digital for North America at Chappuis Halder & Co., discussed how these tools can be leveraged to develop a lasting competitive advantage ...
SYS-CON Events announced today that Dasher Technologies will exhibit 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. Dasher Technologies, Inc. ® is a premier IT solution provider that delivers expert technical resources along with trusted account executives to architect and deliver complete IT solutions and services to help our clients execute their goals, plans and objectives. Since 1999, we'v...
There is only one world-class Cloud event on earth, and that is Cloud Expo – which returns to Silicon Valley for the 21st Cloud Expo at the Santa Clara Convention Center, October 31 - November 2, 2017. Every Global 2000 enterprise in the world is now integrating cloud computing in some form into its IT development and operations. Midsize and small businesses are also migrating to the cloud in increasing numbers. Companies are each developing their unique mix of cloud technologies and service...
For financial firms, the cloud is going to increasingly become a crucial part of dealing with customers over the next five years and beyond, particularly with the growing use and acceptance of virtual currencies. There are new data storage paradigms on the horizon that will deliver secure solutions for storing and moving sensitive financial data around the world without touching terrestrial networks. In his session at 20th Cloud Expo, Cliff Beek, President of Cloud Constellation Corporation, d...
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.