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DELTYBA (delamanid), antituberculosis agent
INFECTIOLOGY - New medicinal product
Opinions on drugs -
Posted on
Apr 06 2016
Reason for request
Inclusion
Moderate improvement in combination with other antituberculosis agents in the treatment of multidrug-resistant pulmonary tuberculosis
- DELTYBA has Marketing Authorisation in multidrug-resistant pulmonary tuberculosis in combination with other antituberculosis agents.
- The evidence for its efficacy is based on very limited data.
- Its safety profile appears favourable; the only important risk, that has been identified, isprolongation of the QT interval, which can be problematic if used in combination with other drugs that prolong the QT.
- The WHO and the French High Council for Public Health (HCSP) have included it in the strategy for treating multidrug resistant tuberculosis with a combination of more than one antituberculosis drug chosen in accordance with in-vitro resistance, contraindications and intolerance risks.
- DELTYBA must be prescribed by doctors experienced in the treatment of multidrug resistant tuberculosis, with the choice of treatment protocol based on the recommendations of an expert panel (e.g. CNR-MyRMA [French National Reference Centre for Mycobacteria and Mycobacteria Resistance to Antituberculosis Agents]).
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| moderate |
- |
Therapeutic use
|
- |
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