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news.The European Commission (EC) has granted conditional approval to Janssen-Cilag International's (Janssen's) Sirturo (bedaquiline) in the European Union (EU), for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients.
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Sirturo is indicated when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of bedaquiline in December 2013.
Janssen head of R&D, Global Public Health Wim Parys said the company is delighted that Sirturo has been approved for use in the EU, as it represents a significant step forward in helping address a very serious global public health issue.
"We will continue to work with partners and relevant authorities to ensure Sirturo is used correctly and appropriately, and we recognise the importance of educational efforts in informing physicians and patients about appropriate use," Parys said.
Scientists at Janssen have discovered Sirturo, which has a unique mechanism of action that inhibits mycobacterial ATP (adenosine 5’triphosphate) synthase, an enzyme that is necessary for the generation of energy in Mycobacterium tuberculosis.
The EC approval is based on 24-week data from the Phase II clinical development programme, which included a controlled, randomized trial that assessed the safety and efficacy of the drug versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen (TMC207-C208) and an open-label study (C209).
The company said that the durability of effect was supported by 120-week data from the Phase II controlled, randomized trial.
Under the provisions of the approval, Janssen will support a Phase III trial to further substantiate the benefit-risk for Sirturo and define its optimal use, with regards to the number and types of agents that are needed in combination, and its optimal treatment duration.
Image: Janssen’s Sirturo in approved for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis. Photo: courtesy of Carlos Porto/ freedigitalphotos.net