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.