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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: FDA: Proposed J&J Tuberculosis Drug Appears Safe




 

Fox Business (11.26.12) Aids Weekly Plus

The Johnson & Johnson (J&J) pharmaceutical company has applied for accelerated approval by the Food and Drug Administration (FDA) of the drug bedaquiline as a treatment for a form of drug-resistant TB. Accelerated approval is a type of temporary approval that is based on less clinical data than are required for regular approval. The drug will be reviewed on November 28 by the FDA’s Anti-Infective Drug Advisory Committee made up of non-FDA medical experts. Bedaquiline is designed to work in a different way to treat TB and would be used in combination with other drugs. The FDA has asked the advisory panel to vote on whether J&J’s data provide “substantial evidence” of the safety and efficacy of bedaquiline as a TB treatment when used with other drugs. The agency stated that the safety data currently available for the drug suggest that it is safe, but there is a potential for the highest dose to cause a small change in heart rhythm. The agency released a review of the product in advance of the meeting.



 


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Information in this article was accurate in November 26, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.