FDA advisory panel backs efficacy of J&J TB drug -J&J
Nov 28 (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 spokesman Geoff Curtis said the panel of outside medical experts, in a vote of 18 to 0, said clinical 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. (Reporting by Ransdell Pierson; Editing by Jan Paschal)