FDA Says Johnson & Johnson's TB Drug Appears Safe
Published: Nov 27, 2012
The Food and Drug Administration said a proposed experimental drug being developed by a unit of Johnson & Johnson JNJ -0.93% to treat a drug-resistant form of tuberculosis appeared "safe and well-tolerated." J&J is seeking approval of a drug called bedaquiline as a tuberculosis treatment. The company is seeking what is called accelerated approval of bedaquiline, which is a type of temporary approval based on less clinical data than required for regular approval. The product will be reviewed Wednesday by the FDA's anti-infective drugs advisory committee, which is made up of non-FDA medical experts. The agency released a review of the product Monday in advance of the meeting. Tuberculosis is a bacterial infection that mostly involves the lungs. It is treated with a combination of four drugs for at least six months, according to the National Heart, Lung, and Blood Institute. However, there is evidence that some forms of TB can't be treated with currently available drugs, which the FDA said "threatens to erode the progress made in the world-wide control of tuberculosis." Bedaquiline is designed to work in a new way to treat TB and would be used with other drugs.