SIRTURO (bedaquiline), antituberculosis agent

INFECTIOUS DISEASE - New medicinal product

Opinions on drugs - Posted on Sep 07 2015

Inclusion

SIRTURO has Marketing Authorisation for multidrug resistant pulmonary tuberculosis in combination with other antituberculosis agents.
The proof of its efficacy is based on very limited data (phase II studies) which show that the combination of bedaquiline with an appropriate combination antibiotic therapy leads to faster bacteriological sputum conversion.
Increased mortality observed in studies, unexplained at this time, restricts its indication to adults, when another effective treatment regimen cannot be proposed for reasons of resistance or intolerance. The Marketing Authorisation for SIRTURO depends on the performance of a phase III study that will enable a decision to be made with a better level of evidence about its clinical benefit relative to its safety profile.
WHO and the HCSP [French High Council for Public Health] have included this in the strategy for treating multidrug resistant tuberculosis by a combination of several antituberculosis medicines chosen in accordance with in-vitro resistance, contraindications and intolerance risks.
The Committee recommends the restriction of SIRTURO prescription to physicians experienced in the treatment of multidrug resistant tuberculosis and after an opinion from a group of experts to choose the treatment regimen (e.g.: CNR-MyRMA [French National Reference Centre for Mycobacteria and Mycobacteria Resistance to Antituberculosis Agents]).

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