World Tuberculosis Day: Three new medicines recommended by EMA in last six months for patients with multidrug-resistant tuberculosis

Last Updated on April 9, 2014 by Joseph Gut – thasso

April 09, 2104 – Usually, we talk and present here issues on health and disease, therapies notwithstanding which are based on the genetic background (i.e. predisposition) of the individual.  Another aspect of predisposition for dieseas is of course the situation where the genetics of a disease causing agent is at fault. As in the cases of development of resistance of disease causing agents against certain drugs.

Take tuberculosis. Tuberculosis 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). Situro has been approved in the meantime.

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.

Look here for information on World Tuberculosis Day.

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.