November 28, 2012 / 9:50 PM / in 5 years

FDA advisory panel backs efficacy of J&J TB drug

(Reuters) - An advisory panel to the U.S. Food and Drug Administration on Wednesday voted that data suggest an experimental Johnson & Johnson drug for multidrug-resistant tuberculosis is effective, the drugmaker said.

The medicine, called bedaquiline, is a member of a new class of drugs that target adenosine triphosphate synthase, an enzyme the tuberculosis bacterium needs to generate its energy.

J&J said the panel of outside medical experts, in a vote of 18 to 0, found that trial data support the efficacy of bedaquiline in adults, taken in combination with standard treatments.

In September, the FDA granted priority review of the medicine, based on data from two mid-stage trials that tested it among patients with tuberculosis that is resistant to standard drugs.

J&J is hoping the agency will grant accelerated approval of the drug, on the basis of favorable data from mid-stage trials. The company plans to begin a larger Phase 3 study in the fourth quarter.

In a pair of completed Phase 2 trials, two doses of the medicine were tested for 24 weeks, in combination with standard treatments, followed by continuation of standard therapy for a year to 18 months.

The planned larger trial will involve nine months of treatment with bedaquiline, in combination with standard drugs, compared with standard drugs alone for the same period. The total nine-month treatment period would be far shorter than the current 18- to 24-month treatment period for multidrug-resistant tuberculosis drugs recommended by the World Health Organization, J&J said.

Cowen and Co has forecast peak annual sales of $300 million for bedaquiline, which would make it a fairly modest product for the diversified healthcare company.

Multidrug-resistant tuberculosis is caused by strains of the bacterium that have become resistant to at least isoniazid and rifampin, the two most potent drugs for TB.

Resistance to anti-TB drugs can occur when they are misused or mismanaged, for instance when patients don’t complete their full course of treatment or when doctors prescribe the wrong treatment, wrong dose or length of time taking the drugs.

An estimated 8.7 million people in 2011 fell ill with tuberculosis - which is spread by coughing and sneezing -- while 1.4 million died from the disease, according to the World Health Organization. About 310,000 cases of multidrug-resistant TB were reported the same year, the organization said, with almost 60 percent in India, China and Russia.

Reporting by Ransdell Pierson; Editing by Jan Paschal and Carol Bishopric

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