EMA has recommended approval of a new drug against TBC

EMA has recommended granting a conditional marketing authorization for a new medicinal product affecting the multi-resistant pulmonary TBC.

It is the Sirturo drug having bedaquiline as its active substance. In EU tuberculosis belongs among rare diseases. Multidrug-resistant tuberculosis is defined as the tuberculosis resistant at least to isoniazid and rifampicin – the two main anti-tuberculosis drugs used as the standard therapy. The multidrug-resistant tuberculosis is connected with a high degree of mortality and represents significant endangerment of public health. The patients affected by resistant mycobacteria strains do not react to the therapy adequately and can even spread the infection among other people. Sirturo is the first representative of a new drug group against mycobacteria. The recommendation to award the marketing authorization decision is conditioned by additional clinical studies to be performed by the producer. The CHMP standpoint concerning the Sirturo medicinal product will be handed over to the European Committee that will award the marketing authorization decision.

The whole paper can be found here.


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