The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorization of Deltyba (delamanid) and Para-aminosalicylic acid Lucane (para-aminosalicylic acid), two treatment options for use in combination with other medicines against multidrug-resistant tuberculosis.
Multidrug-resistant tuberculosis is defined as tuberculosis caused by Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampicin, which are two anti-tuberculosis medicines used in standard treatment. Approximately 450,000 cases of multidrug-resistant tuberculosis occur globally every year, which corresponds to approximately 5% of the world’s annual burden of tuberculosis. In the European Union, tuberculosis is an orphan indication. It was estimated in 2011 to occur in 2.3 out of 10,000 people.
Multidrug-resistant tuberculosis is associated with a very high mortality rate and poses a significant public-health threat as individuals infected with drug-resistant strains are unable to receive adequate treatment and can potentially spread their infection.
Conditional marketing authorization recommended for Deltyba
The CHMP recommended granting a conditional marketing authorization for Deltyba (delamanid), a product of Otsuka Pharmaceutical Co. Ltd., for the treatment of adult patients with pulmonary infections due to multidrug-resistant tuberculosis when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability.
The Committee considered that Deltyba responds to the high unmet need for new treatment options for pulmonary multidrug-resistant tuberculosis. The data supplied by the applicant show that the medicine’s benefits outweigh its risks but are not yet comprehensive, therefore the CHMP concluded that additional studies on the long-term effectiveness of Deltyba should be conducted.
This is the outcome of a re-examination of the CHMP’s previous recommendation to refuse granting of a marketing authorization for Deltyba adopted on July 25.
Marketing authorization recommended for Para-aminosalicylic acid Lucane
The Committee also recommended granting a marketing authorization for Para-aminosalicylic acid Lucane, a product from Lucane Pharma SA, against multidrug-resistant tuberculosis in adults and pediatric patients when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability.
Para-aminosalicylic acid, of which Para-aminosalicylic acid Lucane is a new formulation, 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. Its use resumed in the 1990s with the emergence of multidrug-resistant tuberculosis. Para-aminosalicylic acid Lucane is currently available in France in a compassionate-use program.
The approval of these two medicines highlights the Agency’s ongoing efforts to tackle the growing public-health challenge of antibacterial resistance.
Date: November 22, 2013