CHMP recommends approval of new TB treatments in Europe

At the November 2013 meeting of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) recommended the authorisation of Deltyba (delamanid, Otsuka) and Para-aminosalicylic acid Lucane (para-aminosalicylic acid, Lucane) for use in combination with other medicines against multidrug-resistant tuberculosis (MDR-TB).  Both products have orphan drug status in Europe.

Case reports of MDR-TB have been on the rise, both in developing countries in Asia and Africa and in eastern Europe, and there has been growing concern over the threat this poses to public health.    MDR-TB is associated with a high mortality rate, with the World Health Organization (WHO) estimating that in 2012 the 450’000 emergent cases resulted in around 170’000 deaths.  Additionally, unsuccessful treatment of MDR-TB cases may lead to an increase in infection with multidrug resistant strains in Europe.

Link to EMA press release.

Link to WHO information on MDR-TB.

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