Bedaquiline (Sirturo™) and delamanid (Deltyba™) are the first new TB medicines to be released onto the market in more than 40 years for the treatment of multidrug-resistant tuberculosis (MDR-TB). Since their release, these medicines have been used to treat MDR-TB patients as well as TB patients who have experienced life-altering side effects or developed intolerance or resistance to some second-line TB medicines.
Bedaquiline is a new antibacterial medicine that interferes with bacterial energy metabolism and is indicated as part of combination therapy in the treatment of adults with pulmonary MDR-TB. Delamanid, a new medicine with a novel mechanism of action, is a cell wall synthesis inhibitor used for the treatment of MDR-TB under defined conditions.
While these new medicines have shown beneficial effects in studies, including Phase IIB trials, Phase III trials have not been completed. However, given the serious threat posed by MDR-TB, some country regulatory authorities have used an accelerated procedure for the approval of new TB medicines to ensure that eligible patients may benefit when the medicines are used under certain conditions.