9-Jan-13 8:00 AM  CST

First Drug To Treat Multi-drug Resistant Tuberculosis Approved

The Food and Drug Administration has approved Sirturo (bedaquiline) to treat multi-drug resistant pulmonary tuberculosis (TB).  This drug comes into play when other alternatives are not an option.  TB is a deadly disease that affects approximately 9 million individuals globally.  According to the Centers for Disease Control (CDC), in 2011 more than 10,500 patients became ill with TB in the United States. You may be wondering how multi-drug resistant TB occurs in patients and how they become so ill.  Tuberculosis is caused by Mycobacterium Tuberculosis and is contracted from person to person through the air and is highly contagious. 

An FDA spokesperson recently commented on the drug approval.  “Multi-drug resistant tuberculosis poses a serious health threat throughout the world, and Sirturo provides much-needed treatment for patients who don’t have other therapeutic options available,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.  “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,” said Cox. 

Janssen Therapeutics manufactures Sirturo.  The new drug carries a black boxed warning and will be marketed with educational materials to ensure that the medication is dispensed and used properly.  To date, this drug is only approved in the United States.       

1. VOA News Reports.  “US Approves Drug-Resistant Tuberculosis Treatment.”  Voice of America.  Web.  1 Jan 2013.         

2. Walsh, Sandy.  “FDA Approves Sirturo.”  FDA.  Web.  31 Dec 2012.

For additional information on this article, please contact:
Jennifer S. O'Reilly
Source: NPTAnews  

Tendenci™ User Home © 2004 Tendenci™ software by Schipul - "The Web Marketing Company" | www.schipul.com