FDA grants accelerated approval to drug to treat MDR-TB

"The U.S. Food and Drug Administration [on Monday] approved Johnson & Johnson's drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally," the Wall Street Journal reports. "The drug, Sirturo, will treat patients with multidrug-resistant tuberculosis, or MDR-TB, a possibly fatal disease that affects as many as 630,000 people worldwide who can't be cured with existing therapies alone," the newspaper notes (Walker/Tadena, 1/2).

But the FDA "cautioned that the new drug should be used sparingly," Agence France-Presse writes. "Sirturo will carry a [black box] warning to alert patients and health professionals that the drug can affect the heart's electrical activity, which could lead to an abnormal and potentially fatal heart rhythm," and "that nine patients who received Sirturo died -- compared with two patients who received a placebo," the news agency adds (1/1). The New York Times notes the "consumer advocacy group Public Citizen opposed [the drug's] approval in a letter to the F.D.A. in mid-December," while "Doctors Without Borders and the Bill & Melinda Gates Foundation, both active in the fight against tuberculosis and other global diseases, applauded the FDA's decision." The newspaper notes, "Johnson & Johnson will conduct larger clinical trials to investigate whether the drug performs as predicted" (Thomas, 12/31).

http://www.kaiserhealthnews.orgThis article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.


Posted in: Disease/Infection News | Pharmaceutical News

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