FDA Approves New Tuberculosis Drug

THE JOURNAL RECORD, June 24, 1998 | Go to article overview

FDA Approves New Tuberculosis Drug


WASHINGTON (AP) -- The Food and Drug Administration has approved the first new tuberculosis drug in 25 years, a medication designed to cut the number of pills patients must take and to reduce the risk that the bacteria will become a deadly, drug-resistant type.

The FDA said Tuesday that it has approved rifapentine, which is marketed under the name Priftin by Hoechst Marion Roussel of Kansas City, Mo. The United States is the first country to approve the drug.

An advisory panel voted 10-1 to recommend approval earlier this month for the drug that can cut significantly the number of pills a patient has to take to cure the pulmonary TB. FDA officials say this is important because it makes patients more likely to complete their therapy. Failure to complete therapy could lead to bacteria in a patient becoming resistant to antibiotics. The World Health Organization estimated there will be 90 million new cases of tuberculosis and 30 million deaths worldwide in the decade of the 1990s. According to the Centers for Disease Control and Prevention, about 19,000 cases were diagnosed in the United States in 1997. …

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