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J&J files TB drug bedaquiline in Europe

Could become first new drug for multidrug resistant forms of the disease in decades

Johnson & Johnson (J&J) has filed for approval in Europe of its tuberculosis (TB) drug bedaquiline, which could become the first new drug for multidrug resistant (MDR) forms of the disease in decades.

J&J's Janssen subsidiary is seeking approval of bedaquiline (formerly TMC207) as an oral treatment used alongside other antibiotics for pulmonary MDR-TB in adults, which is the second biggest reason for adult mortality caused by infectious disease after malaria.

If approved by the European Medicines Agency (EMA), bedaquiline would be the first drug with a new mechanism of action for TB in more than 40 years, and would also be the first and only drug specifically indicated for the disease.

Bedaquiline was discovered at J&J subsidiary Janssen Research & Development and works by inhibiting ATP synthase - the proton pump of Mycobacterium tuberculosis - which is a different mechanism to current TB drugs such as quinolone antibiotics which inhibit DNA gyrase.

Janssen has also submitted bedaquiline for approval in the US, where the application has been granted priority review status.

After a dearth of medical research into new treatments for TB in the past couple of decades, pharma manufacturers have started to renew their attention on the disease.

In June, a consortium of pharma companies and academic researcher formed a new partnership to try to accelerate the pace of drug discovery in this area, in particular to find treatment regimens that can be delivered more simply to patients.

Meanwhile, other pharma companies are stepping up research on MDR-TB. Otsuka recently reported positive phase II results of another drug with a novel mechanism of action - called delamanid - which works by inhibiting mycolic acid synthesis.

The appearance of new medicines comes at a critical juncture. A study reported in The Lancet (August 30) found that more than 40 per cent of MDR-TB cases which do not respond to the most commonly used first-line therapies isoniazid and rifampicin were also resistant to second-line drugs such as quinolones.

The emergence of extensively-drug resistant (XDR) strains of TB is "worrying", according to the authors, who found that around 6-7 per cent of TB cases among eight countries surveyed fell into the category.

3rd September 2012

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