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Subscribe to RSSThe Food and Drug Administration on Monday approved a Johnson & Johnson tuberculosis drug that is the first new medicine to fight the deadly infection in more than four decades.
The agency approved J&J's pill, Sirturo, for use with older drugs to fight a hard-to-treat strain of tuberculosis that has not responded to other medications. However, the agency cautioned that the drug carries risks of potentially deadly heart problems and should be prescribed carefully by doctors.
Roughly one-third of the world's population is estimated to be infected with the bacteria causing tuberculosis. The disease is rare in the U.S., but kills about 1.4 million people a year worldwide. Of those, about 150,000 succumb to the increasingly common drug-resistant forms of the disease. About 60 percent of all cases are concentrated in China, India, Russia and Eastern Europe.
Sirturo, known chemically as bedaquiline, is the first medicine specifically designed for treating multidrug-resistant tuberculosis. That's a form of the disease that cannot be treated with at least two of the four primary antibiotics used for tuberculosis.
The standard drugs used to fight the disease were developed in the 1950s and 1960s.
"The antibiotics used to treat it have been around for at least 40 years and so the bacterium has become more and more resistant to what we have," said Chrispin Kambili, global medical affairs leader for J&J's Janssen division.
The drug carries a boxed warning indicating that it can interfere with the heart's electrical activity, potentially leading to fatal heart rhythms.
"Sirturo provides much-needed treatment for patients who have don't have other therapeutic options available," said Edward Cox, director of the FDA's antibacterial drugs office. "However, because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options."
Nine patients taking Sirturo died in company testing compared with two patients taking a placebo. Five of the deaths in the Sirturo group seemed to be related to tuberculosis, but no explanation was apparent for the remaining four.
Despite the deaths, the FDA approved the drug under its accelerated approval program, which allows the agency to clear innovative drugs based on promising preliminary results.
Last week, the consumer advocacy group Public Citizen criticized that approach, noting the drug's outstanding safety issues.
"The fact that bedaquiline is part of a new class of drug means that an increased level of scrutiny should be required for its approval," the group states. "But the FDA had not yet answered concerns related to unexplained increases in toxicity and death in patients getting the drug."
The FDA said it approved the drug based on two mid-stage studies enrolling 440 patients taking Sirturo. Both studies were designed to measure how long it takes patients to be free of tuberculosis.
Results from the first trial showed most patients taking Sirturo plus older drugs were cured after 83 days, compared with 125 days for those taking a placebo plus older drugs. The second study showed most Sirturo patients were cured after 57 days.
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Leave a Comment:
If the drug is effective, why are they waiting 40 years? Or, was this article written by someone who has not yet mastered our language, and edited by someone in the same boat?
Sounds like a reading comprehension problem to me. Perfectly clear that it is the first drug in 40 years to be approved. As in, "We have been using the same drugs for 40 years. Now we have a new one."
440 Guinea pig people doesn't sound like a lot of test subjects to me. So the FDA says this is a "Hail Mary" drug to be given only to those without other therapeutic hope?
If the bug isnt responding to anything else yes we should accept higher risk for the only new drug to come out in 40 years that treats TB. The patient will die without the drug, give them a chance at living.
The drug is being fast tracked because people are desperate for a cure and millions of people have died from it. AIDS treatments were also fast tracked because aggressive protesters made a big deal out of the fact that the FDA takes a long time to approve drugs. The counter argument has always been what happens if the cure ends up being ineffective and does more harm then good. At that point both the FDA and the drug maker are libel for massive lawsuits.
The drug was discovered in 2005 in Belgium, but only got into trials in people over the past 2-3 years. It kills multidrug resistant TB, which is a major advance given that MDR rates are climbing astronomically and there are very few drugs that have any effect. The FDA has said that "yes, it can be used to treat MDR" but are still requiring further safety tests [it slowed the heart rhythm in some people who took it].
Dear Friends:
Hurray! Invest! Invest! Can we wipe out Tuberculosis?