Johnson & Johnson seeks approval for MDR-TB medicine
The drug, called bedaquiline, would be the first new class of drug used against the deadly infection in more than four decades. In addition, it would be the first medicine specifically used to treat multi-drug-resistant TB, according to the Washington Post.
MDR-TB is an increasingly common form of the infection in which at least two of the primary front-line TB drugs are ineffective.
J&J's Janssen research and development unit developed the drug, which has been tested in hundreds of patients with MDR-TB in two studies that lasted for six months. Some patients have been observed on the medication for approximately a year and six months.
The pharmaceutical company said that it plans to begin late-stage testing this fall to compare the effects of bedaquiline to placebos over nine months in 600 patients. Each patient in the study will also take six other drugs that are considered standard in TB treatment. One goal of the study is aimed at reducing the recommended treatment time for MDR-TB from 18 to 24 months to nine months.
Dr. Wim Pays, the head of infectious diseases at Janssen, said that the company also plans to seek approval for bedaquiline in countries where TB is very common, according to the Washington Post.