Johnson & Johnson on Monday said it is asking US regulators to approve an experimental drug against multidrug-resistant TB. If approved, J&J’s bedaquiline would be the first new TB drug in more than four decades as well as the first drug specifically for treating MDR TB.
Bedaquiline, created by J&J’s Janssen Research and Development unit, has been tested in several hundred MDR TB patients in two mid-stage trials lasting six months. Some patients were followed for 1.5 years.
This fall, a late-stage trial will compare bedaquiline in combination with standard therapies for TB against placebo pills plus standard treatments. The trial, which will enroll about 600 patients, also will seek to determine whether resistant TB can be treated in nine months - a big reduction from the 18-24 months currently recommended by the World Health Organization.
The company also will apply for regulatory approval of bedaquiline in countries where TB is widespread, said Dr. Wim Pays, Janssen’s head of infectious diseases.
Date of Publication
Linda A. Johnson
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