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Janssen's Sirturo wins backing for conditional EU licence

CHMP recommends first-in-class multidrug-resistant tuberculosis treatment


European regulatory advisors have recommended Janssen's first-in-class orphan drug Sirturo (bedaquiline) be approved as a treatment for multidrug-resistant tuberculosis. 

The CHMP issued a 'positive opinion' for Janssen's Sirturo as part of a combination treatment for pulmonary multidrug-resistant TB in adults for whom either drug resistance or tolerability otherwise blocks an effective treatment regimen.

If the decision is ratified by the European Commission, which usually follows CHMP approval within three months, the drug would have a conditional licence because comprehensive benefit-risk data is not yet available and Janssen will have to conduct further studies on Sirturo.

Sirturo is the first treatment of its kind and works by inhibiting mycobacteria ATP (adenosine 5'-triphosphate) synthase, an enzyme that is essential for the generation of energy in Mycobacterium tuberculosis.

The Committee considered that Sirturo could contribute to responding to the high unmet medical need for new treatment options for pulmonary multidrug-resistant TB, which is associated with a high mortality rate and poses a significant public-health threat.

TB effects an estimated 2.3 out of 10,000 people in the European Union, where it is an orphan indication.

In recent years, the burden of tuberculosis resistant to first-line therapy of at least isoniazid and rifampicin, the two major anti-tuberculosis treatments, has increased rapidly in the absence of new treatment options, a situation that finally looks to be improving somewhat.

Sirturo is the third positive opinion granted by the CHMP in the last two months and follows CHMP recommendations for the multidrug-resistant tuberculosis treatments Otsuka's Deltyba and Lucane Phamra's Para-aminosalicylic acid Lucane.

Nevertheless, even with these new treatments poised to soon reach the market, continued research on the best way to use them will be needed, according to Medicins Sans Frontieres. Earlier this year the charity backed a WHO/Global Fund report that concluded an extra $1.3bn needs to be raised each year until 2016 if multi-drug resistant TB is to be tackled effectively.

Article by
Dominic Tyer

23rd December 2013

From: Sales, Regulatory



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