Tuberculosis Treatment – New Protocols
Public consultations by the European Medicines Agency (EMA) on development of new drugs for tuberculosis have started. The issue concerns not just a couple of new drugs, but development of breakthrough new schemes for treatment of the disease. During public consultations up to January 31, 2017, it is suggested to discuss potential supplement to Guidelines for assessment of drugs for bacterial infections. It is quite logical. Current methods of TB treatment are complex and not quite effective (particularly in case of multidrug resistance). Reseachers are looking for new TB drugs and drug combinations, simpler to use and to overcome drug resistance. A shift towards development of principally new TB treatment schemes has already emerged. Supplement to guidelines addresses the above and formulates regulatory requirements of European Union for the data required to approve new drugs or their combinations. The supplement also provides recommendations for assessment of efficacy of new drugs and treatment schemes, including newly approved drugs, new treatment regimen, including at least one new product, and the role of biomarkers for forecasting the drug efficacy in the process of clinical development.