A movement to promote and conduct research on the treatment and prevention of drug-resistant tuberculosis, with a commitment to address the substantial existing gaps in our knowledge and to help provide access to an effective cure and prophylaxis of drug-resistant tuberculosis throughout the world.
Nearly nine million people will develop tuberculosis (TB) in the world this year; at least 500,000 of these cases will have multidrug-resistant tuberculosis (MDR-TB). Some will receive treatment. However, we know little about the best ways of treating drug-resistant TB (DR-TB) and preventing tuberculosis in people who come in contact with DR-TB patients. Lacking a strong scientific basis in prescribing treatment regimens, existing TB treatments are often ineffective. TB control efforts require new evidence-based knowledge about optimal treatment regimens, prophylaxis, and, possibly, regimens involving new TB drugs, in order to address the growing health threats of MDR-TB and extensively drug-resistant (XDR) TB.
Bedaquiline Receives Second Conditional Marketing Authorization
On December 19, the European Medicines Authority (EMA) advisory panel recommended conditional marketing authorization of bedaquiline (brand name: Sirturo) for treatment of MDR-TB in combination with other agents. This is the second conditional authorization for bedaquiline, which received such a decision from the U.S. FDA in December, 2012. Both authorizations are conditional pending results of a Phase III study and compliance with other regulatory requirements. This decision is an important step in wider access to new anti-TB drugs.
Recent News and Announcements
The third-largest private funder in global TB research, AstraZeneca, has announced it will no longer conduct early-stage research on tropical diseases, including tuberculosis and malaria. The company was a substantial contributor to TB R&D. Coupled with Pfizer’s discontinuation of anti-infectives research last year, the TB R&D pool of private investors continues to shrink. AstraZeneca’s decision [...]
A RESIST-TB and MSF collaboration entitled “Principles for designing future regimens for multidrug-resistant tuberculosis is featured in the January issue of the Bulletin of the World Health Organization. The publication outlines eight key principles for designing future treatment regimens to ensure that they will be clinically effective and programmatically practicable. View the publication here.
The US National Institute for Allergy and Infectious Diseases (NIAID) have scheduled to continue the webinar series on Clinical Research Design and Conduct. This program is being coordinated by the DMID International Clinical Studies Support Center (ICSSC) located at FHI 360. Session II of the Clinical Research Design series will be: Wednesday, 8 January 2014 [...]
The EMA advisory panel recommended approval of delamanid (brand name: Deltyba) for treatment of MDR-TB on Thursday, November 21. This represents a reversal of the EMA denial of approval just last July. The EMA attributes its reversal to submission by Otsuka of further safety and efficacy data on use of the drug for 6 months. [...]
View the Global TB Report here