World TB Day – three new medicines recommended in last six months for patients with multidrug-resistant tuberculosis

News 21/03/2014

World TB DayTuberculosis is an infection caused by Mycobacterium tuberculosis that primarily affects the lungs. In 2012, an estimated 8.6 million people developed tuberculosis and 1.3 million died from the disease.

Although tuberculosis is slowly declining worldwide, multidrug-resistant tuberculosis still poses a serious public health challenge. It often affects people from the most vulnerable communities, such as migrant workers, refugees, displaced persons, prisoners or drug users.

Multidrug-resistant tuberculosis is associated with a substantial mortality rate and poses a significant public-health threat as individuals infected with drug-resistant strains often do not receive adequate treatment and can potentially spread their infection.

Over the past six months, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation to three medicines for the treatment of multidrug-resistant tuberculosis.

These include Sirturo (bedaquiline) and Deltyba (delamanid) which are both the first representatives of a new class of medicines against mycobacteria, and Para-aminosalicylic acid Lucane (para-aminosalicylic acid).

The Agency's CHMP considered that Sirturo and Deltyba both respond to the high unmet need for new treatment options for pulmonary multidrug-resistant tuberculosis. The data supplied by the applicants demonstrate that the medicines' benefits outweigh their risks, but are not yet comprehensive; therefore, the CHMP recommended granting conditional approval and the companies must conduct additional studies on the long-term effectiveness of the medicines.

Para-aminosalicylic acid Lucane is a new formulation of Para-aminosalicylic acid, which was the second medicine to be introduced for the treatment of tuberculosis in 1946, and was part of standard-of-care treatment until the 1970s. It is recommended in the treatment of multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

About tuberculosis and World TB Day

The EMA supports World TB Day. Falling on 24 March each year, World TB Day is designed to build public awareness that tuberculosis today remains an epidemic in much of the world, mostly in developing countries.

World TB Day commemorates the day in 1882 when Dr Robert Koch announced to the scientific community that he had discovered the cause of tuberculosis, the TB bacillus. At the time of Koch's announcement in Berlin, TB was raging through Europe and the Americas, causing the death of one in every seven people. Koch's discovery opened the way towards diagnosing and curing tuberculosis.

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