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.
The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency, and the United States’ Food and Drug Administration have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
Representatives from the three regulatory agencies met in Vienna on 26-27 April 2017 and discussed recommendations for the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. They identified a number of areas where the data requirements in the three regions could be streamlined. The three regulatory agencies will be working to update their guidance documents respectively.
Read the full press release here.
Recent News and Announcements
On Thursday, June 22nd from 8:30 to 9:30 EST (14:30-15:30 CEST, SAST), Dr. Yongge Liu, Director of Diagnostics at Otsuka Novel Products, gave a presentation on LAM (Lipoarabinomannan) as a Pharmacodynamic Biomarker and Drug Development Tool for TB. Otsuka Pharmaceutical is developing an assay that can measure the concentration of LAM, which is showing promise as a […]
New research suggests the bacteria that cause tuberculosis alter their metabolism to combat exposure to antimicrobials, and that these metabolic “escape pathways” might be neutralized by new drugs to shorten the troublesome duration of therapy. Researchers studied the proteomic responses of the bacteria to five compounds – isoniazid, rifampicin, moxifloxacin, mefloquine and bedaquiline – and […]
In a Personal View published in The Lancet Infectious Diseases, Amber Kunkel, Jennifer Furin and Ted Cohen argue that resistance concerns should not forestall use of bedaquiline in patients with XDR-TB. Their position in favour of increased access to bedaquiline for these patients is based on three arguments. First, the use of drug combinations that include […]
Leaders from the governments of France and the Netherlands today urged funding for new treatment and prevention tools against drug-resistant tuberculosis at a high-level meeting in Brussels, citing the scope of the problem in Europe. “Because of drug resistance, TB is evolving to become an untreatable disease for a growing number of people,” said Michèle […]
DR-TB STAT and the Sentinel Project will host a webinar, MDR-TB Treatment with Bedaquiline in Children and Adolescents: Global Recommendations and Program Experience in Belarus on 26 May 2017 from 10-11am EDT. Co-sponsored by DR-TB STAT and the Sentinel Project, this webinar will begin with an update on global guidelines for the use of new […]