TB Alliance launches landmark Phase 3 clinical trial aimed at shortening duration of TB treatment

TB Alliance has announced that it will conduct a landmark Phase 3 clinical trial aimed at shortening the treatment of drug sensitive and MDR-TB. The trial known as STAND (Shortening Treatments by Advancing Novel Drugs) will test the PaMZ drug regimen composed of two drug candidates not yet approved for TB, PA-824 (Pa) and moxifloxacin (M), in addition to existing antibiotic pyrazinamide (Z). The STAND trial will span over 50 sites in 4 continents and is expected to shorten the treatment of MDR-TB from 2 years to 6 months.

Sirturo (bedaquiline) approved for conditional use in European Union to treat MDR-TB in adults

The European Medicines Agency (EMA) has recently approved Sirturo (bedaquiline) for conditional use in the European Union for adults suffering from pulmonary MDR-TB.

The press release from Multimedia News Release can be found at:

http://www.multivu.com/mnr/65014-sirturo-treatment-multi-drug-resistant-tuberculosis

Back in December 2012, the same drug was approved by the US Food and Drug Administration. The blog post highlighting that announcement can be found at:

EMA Reverses Opinion on Delamanid for MDR-TB

Source: European Medicines Agency http://www.ema.europa.eu

On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) recommended the granting of a conditional marketing authorisation for the medicinal product Deltyba for the treatment of lung infections due to multidrug-resistant tuberculosis when alternative treatments cannot be used due to resistance or intolerance. The company that applied for authorisation is Otsuka Novel Products GmbH.

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