FDA authorizes use of new class of TB drug, first in 40 years
The drug, known as bedaquiline and to be marketed as Sirturo, was developed by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson. Its approval follows a positive review given last month by an FDA advisory panel, according to the New York Times.
FDA Commissioner Margaret Hamburg said bedaquiline will help to treat and cure those patients that put themselves and others at serious risk. She said that TB is now more prevalent than at any other time in history, according to Reuters.
The FDA panel found the drug to be effective, but also acknowledged it poses potential risks. More deaths were seen during clinical trials in the group of patients who took the drug in combination with standard treatments than in the group who took standard treatments alone.
Chrispin Kambili of Janssen's therapeutics unit recently said that the company is studying the higher incidence of deaths but has yet to find a common pattern. He said almost every death was due to a different cause, including one motor vehicle accident, and that the death rate in the placebo group was unusually low.
The FDA's advisors expressed concern that many of the trial patients had elevated liver enzymes, which could be a sign of toxicity, and some had electrical irregularities in their hearts that could potentially be life threatening, the New York Times reports.
Kambili said the drug may not be a major source of revenue for the company because it designed for a small number of patients who do not respond to other treatments. He said it is, however, critically important from a public health standpoint.