* FDA panel, by 18 to 0 vote, says data support efficacy
* J&J aims for accelerated approval of medicine
(Adds details on drug, multidrug-resistant TB, byline)
By Ransdell Pierson
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 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
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.
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,
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