EMA conditionally approves new drug for multidrug-resistant tuberculosis
Sirturo joins two other new drugs for tackling this type of TB
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline) for use as part of a combination therapy for pulmonary multidrug-resistant tuberculosis in adults when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Multidrug-resistant tuberculosis is defined as tuberculosis that is resistant to at least isoniazid and rifampicin, which are two major 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 cases of TB.
Sirturo is the first representative of a new class of drugs against mycobacteria. The CHMP considered that Sirturo could contribute to responding to the high unmet medical need for new treatment options for pulmonary multidrug-resistant tuberculosis. It recommended granting conditional marketing authorisation because the data on its benefits and risks are not yet comprehensive. Additional studies on the use of Sirturo should therefore be conducted, the Committee said.
Sirturo is the third positive opinion recently granted by the CHMP for a medicine to be used in the treatment of multidrug-resistant tuberculosis, following the November 2013 recommendations for Deltyba (also for a conditional approval) and Para-aminosalicylic acid Lucane.
The CHMP opinion on Sirturo will now be sent to the European Commission for the adoption of a marketing-authorisation decision.
