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J&J's TB drug moves closer to US approval

Bedaquiline recommended as treatment for multidrug resistant forms of the disease

Johnson & Johnson's tuberculosis drug bedaquiline has been recommended for approval in the US, putting it on track to become the first new drug for multidrug resistant (MDR) forms of the disease in decades.

All 18 members of an FDA advisory committee voted unanimously in favour of approval of bedaquiline on the basis of effectiveness.

In phase IIb trials, a 400mg daily dose of the drug significantly reduced the time to sputum culture conversion at eight weeks compared to placebo, which the panel agreed was clear evidence of efficacy.

On the topic of safety the vote was passed by 11 to 7, though some panellists expressed concerns about liver and cardiac effects of the drug, including a disturbance in heart rhythm known as QT interval prolongation.

Documents filed by the FDA reviewer ahead of the panel meeting pointed to a fairly high proportion of patients (33 to 45 per cent) who stopped taking bedaquiline during phase II clinical trials filed in support of the marketing application.

J&J has been granted fast-track review for bedaquiline as there is a pressing need for new tuberculosis (TB) therapies, and said intends to start phase III trials early next year.

The company is seeking approval of the drug alongside other antibiotics for pulmonary MDR-TB in adults, which is the second biggest reason for adult mortality caused by infectious disease after malaria worldwide. It has also submitted it for approval in the EU.

Bedaquiline has a novel mechanism of action - inhibition of the enzyme ATP synthase - unlike current TB drugs such as quinolone antibiotics which inhibit DNA gyrase. 

New drugs are desperately needed because more than 40 per cent of TB cases do not respond to the standard first-line therapies isoniazid and rifampicin, and there are also signs of increasing resistance to second-line drugs such as quinolones.

That means that bedaquiline will likely be reserved for serious cases of MDR-TB, so sales are expected to be fairly modest at less than $500m a year.

29th November 2012

From: Sales

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