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Janssen submits tuberculosis pill to FDA

Published on 04/07/12 at 08:50am
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Janssen has submitted its investigational tuberculosis pill bedaquiline for review by the FDA.

The firm is seeking a licence for bedaquiline to be used as part of a combination therapy for pulmonary, multi-drug resistant tuberculosis.

If approved by the FDA, 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.

Paul Stoffels, worldwide chairman of pharmaceuticals at the firm, said: “The emergence of multi-drug resistant strains of TB is a growing problem that impacts people around the world and is posing a significant new treatment challenge in controlling this serious and deadly disease.

“Although tuberculosis kills approximately 1.4 million people per year and current therapies do not provide adequate control of resistant strains, there have been no new treatment options to treat TB in the last 40 years.

“We believe the […] submission for bedaquiline is an exciting milestone in the development of new TB drugs.”

The drug has a unique mechanism of action that targets adenosine triphosphate synthase, which Mycobacterium tuberculosis - the bacterium that causes tuberculosis - requires to generate its energy.

The regulatory submission is supported by 24-week data from the Phase II clinical trial programme, which includes an open-label study and a controlled, randomised trial.

These studies evaluated the safety and efficacy of bedaquiline versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen.

Janssen is hoping that despite only having mid-stage trial data, the FDA will still approve the drug as it is the first of its kind, and treats a disease that is becoming more resistant to drug treatment.

A Phase III trial – TMC207-C210 – a double-blind study comparing nine months of treatment with bedaquiline versus placebo (both with a background regimen), is planned to start recruiting in the fourth quarter.

This study will evaluate a new regimen of seven drugs for a shorter treatment duration (nine months of treatment) than the current 18 to 24 months WHO standard of care.

Ben Adams

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