Nov 28 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
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
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
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
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)