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J&J Sirturo Wins FDA Approval to Treat Drug-Resistant TB
  Bloomberg News Dec 31 2012

Johnson & Johnson (JNJ) won U.S. regulatory approval for its tuberculosis tablet Sirturo, the first drug in 40 years that provides a new way to treat the contagious lung infection.

The Food and Drug Administration cleared Sirturo to be added to existing therapies for use by adults whose illness is resistant to multiple medicines, the New Brunswick, New Jersey- based company said today in a statement. While tuberculosis was once the leading cause of death in the U.S., the drug-resistant version of the illness affected about 98 people last year, according to the Centers for Disease Control and Prevention.

Finding a treatment for tuberculosis was the passion of Paul Janssen, founder of J&J unit Janssen Pharmaceutica NV, whose sister died of the disease, said Paul Stoffels, J&J's chief science officer and worldwide chairman of its pharmaceuticals group. U.S. approval will help gain clearance in other countries where the disease is more of a burden, he said.

"We'll be able to treat many more people and get them cured for tuberculosis," Stoffels said in a telephone interview. "In the long run, treatment might get simplified, get shorter."

J&J sought approval for the drug known chemically as bedaquiline based on the second of what are typically three phases of clinical trials. The FDA allows for approval before final trials are complete when a drug treats a serious disease and fills an unmet medical need.

The company plans to start a final-phase trial in the first quarter of 2013 to study bedaquiline use for nine months compared with a placebo, Chrispin Kambili, the global medical affairs leader for bedaquiline, said in a telephone interview.

Treatment Time

Typical treatment currently for multidrug-resistant tuberculosis can be as long as two years, Kambili said. The disease is characterized by a long-lasting cough. The study beginning next year will aim to examine 600 patients over five years.

Multidrug-resistant tuberculosis is defined as not responding to the two most popular drugs that are typically first used against the illness: isoniazid and rifampicin, according to the World Health Organization.

There were 8.7 million new cases of tuberculosis worldwide last year, the World Health Organization said in a report. Multidrug-resistant tuberculosis accounted for as many as 400,000 cases in 2011, according to the WHO. Most drug-resistant cases occur in China, India, the Russian Federation and South Africa.

Expedited Review

Approval from the FDA and European authorities where J&J also has applied for marketing authorization will help the company achieve approval in parts of the world where U.S. and EU opinions serve as references, Stoffels said.

J&J will request a voucher from the FDA that allows a company that gained approval for a drug to treat a neglected disease to seek an expedited review of another treatment. The company hasn't chosen which medicine it will use the voucher on if it gets one, Stoffels said.

While more patients responded to the treatment regimen when bedaquiline was added to the lineup, more patients who took the medicine in studies also died, Kambili said.

"We were puzzled by this observation," he said.

In one trial, 10 of 79 bedaquiline-treated patients died compared with two of 81 who took a placebo, the FDA said in a report.

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Reg Gale at

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