FDA Approves New Tuberculosis Drug
January 1, 2013

Johnson & Johnson’s Sirturo Approved For Treatment Of Drug-resistant Tuberculosis

Lee Rannals for redOrbit.com - Your Universe Online

Johnson & Johnson announced on Monday that the U.S. Food and Drug Administration (FDA) has approved a drug for patients with tuberculosis who do not respond to other treatments.

The company said that the drug is the first one in 40 years to tackle the disease using a new methodology, by blocking an energy producing enzyme that tuberculosis bacteria needs to survive.

The FDA approved the drug on Monday following a positive review by an advisory panel last month.

As reported by Reuters, according to the Centers for Disease Control and Prevention (CDC), tuberculosis infected nearly 9 million people globally in 2011, and there were 1.4 million TB-related deaths.

Tuberculosis is an air-spread infection that usually attacks the lungs, but can also affect the brain, the spine and the kidneys.

FDA Commissioner Margaret Hamburg wrote in a blog on the FDA website that tuberculosis is more prevalent now than at any time in history.

Hamburg said the drug will help treat and cure patients who are putting themselves and others at serious health risk.

Sirturo, the Johnson & Johnson drug, has significant potential risks, and will be carrying a warning about an increased rate of death observed in patients who received it, based on a study that saw the group of patients on the drug have a higher risk of dying.

Although the higher risk of dying seems enough of a reason not to approve the drug, advisers argue that the risk of death was due to a different cause for the most part, including a motor vehicle accident.

FDA advisors said there was a greater number of patients with elevated liver enzymes, and elongated QT levels, which could potentially lead to sudden death.

Chrispin Kambili, medical affairs leader for bedaquiline at J&J's Janssen Therapeutics unit, told Reuters that none of the patients during the study died due to serious QT prolongation and there was no unifying findings in the data.

The drug is meant for a small portion of patients who are not responding to the existing treatments for tuberculosis. A study reported in the journal The Lancet in September found that nearly 44 percent of patients with tuberculosis in Russia, Peru and Thailand showed resistance to at least one second-line drug.

Treating drug-resistant tuberculosis can take years, and can cost 200 times as much as treating an ordinary form of the disease.