FDA panel says novel TB drug is safe
The agency's Anti-Infective Drugs Advisory Committee voted unanimously that the results of clinical trials show bedaquiline to be effective in adults to combat durg-resistant TB when used in combination with other treatments. The panel voted 11 to 7 on the drug's safety, according to Reuters.
The panel's decision is not binding, but the FDA usually follows the advice of its advisory committees when deciding whether or not to approve new medicines.
Some of the panel members expressed concern about the drug provoking elevated liver enzymes in some of the trial's recipients. Patients taking benaquiline also had increased in their QT interval, a possible sign of heart electrical irregularities.
Drug-resistant strains of TB have alarmed public health officials around the world. An FDA review noted current trends in resistance could potentially erode recent gains made against the illness. The concern is likely to help J&J gain early approval, according to FierceBiotech.com.
Bedaquiline was originally developed by Tibotec Group NV , which is now a part of J&J subsidiary Janssen Research and Development.