Marketing authorization has been submitted by Johnson & Johnson company Janssen-Cilag International NV to the European Medicines Agency for conditional approval of its investigational drug bedaquiline to be used as part of a combination theory to treat multi-drug resistant tuberculosis.
“MDR-TB is a growing threat to public health and it presents a significant new treatment challenge in controlling this serious and deadly disease,” Wim Parys, the head of the infectious diseases therapeutic area at Janssen, said, Equities.com reports. “This filing underscores our commitment to discover and develop novel medicines and solutions for serious unmet medical needs, and we hope this new treatment will become an important option for patients with MDR-TB.”
Bedquiline, if approved, would be one of the first drugs with a new mechanism of action to fight TB in more than 40 years. It would also be the first to be specifically indicated for MDR-TB, Equities.com reports.
Bedaquiline works by killing the bacterium responsible for tuberculosis by targeting adenosine triphospate synthase, which is an enzyme essential to generating the bacteria’s energy.
Twenty-four week data from the phase II clinical development program was included with the regulatory submissions. The data includes an open-label study and a controlled, randomized trial evaluating the safety and efficacy of bedaquiline versus placebo for treating patients with pulmonary MDR-TB in combination with a background regimen, according to Equities.com.
The company submitted a new drug application for bedaquiline to the FDA in the United States in June, which is under priority review status.