07.01.2013 - The new year could be particularly beneficial for tuberculosis patients. Two new drugs are expected to be approved by the EMA.
After almost 50 years without new treatments against tuberculosis, 2013 might give patients better options. Both Otsuka Pharma from Japan, as well as Johnson & Johnson's German affiliate Janssen-Cilag GmbH, have ongoing approval procedures for the drugs Delamanid and Bedaquilin, respectively. Bedaquilin was approved by the US regulatory authority FDA at the beginning of the new year. The expected European approvals of both medicines by the European Medicines Agency (EMA) are based on Phase II clinical data with Phase III trials continuing in parallel.
Also in Phase II, are another two drugs against TB developed by Bayer from Germany and Sanofi from France. However, both substances – Moxifloxacin (yet approved for other indications) and Rifapentin (also already approved by the FDA) – have not entered European approval procedures yet.
Tuberculosis is mainly spread in Eastern Europe and developing countries but it is also considered an recurring threat for Western Europe. The German Association for Research-Based Pharmaceutical Companies, VFA, estimates that about one third of the earth's population carries the pathogen. Disease outbreaks normally only occur in vulnerable patients following infections by, for example, HIV. Although in general curable, TB has its caveats when compared with other infections of the respiratory tract. Killing mycobacteria without any resistances takes about half a year and comes with nasty side effects. Additionally, many strains have acquired multiple resistances which makes new and better treatment options desirable. That's why the Innovative Medicines Initiative has launched a R&D programme aimed to find better treatments last summer. According to the VFA, some of the upcoming drugs have new modes of actions which makes them especially valuable when mixing different substances for combination therapies. Bedaquilin is the first substance to interfere with energy production of the mycobacteria, while Moxifloxacin is the first to inhibit DNA replication.
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