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Published On: Mon, Jul 9th, 2012

Johnson & Johnson seeks approval of experimental TB drug bedaquiline

Janssen Research & Development, LLC (Janssen) announced last week it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the use of the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.

Image/CDC

MDR-TB is an increasingly common form of tuberculosis in which at least two of the four primary TB drugs don’t work.

J&J says if approved by the FDA, bedaquiline would be the first drug with a new mechanism of action for TB in more than 40 years and the first and only one specifically indicated for MDR-TB.

Paul Stoffels, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson said, “The emergence of multi-drug resistant strains of TB is a growing problem that impacts people around the world and is posing a significant new treatment challenge in controlling this serious and deadly disease.

Stoffels goes on to say, “Although tuberculosis kills approximately 1.4 million people per year and current therapies do not provide adequate control of resistant strains, there have been no new treatment options to treat TB in the last 40 years. We believe the NDA submission for bedaquiline is an exciting milestone in the development of new TB drugs.”

The drug was tested in several hundred patients with multidrug-resistant tuberculosis in two mid-stage studies lasting for six months. Some patients were studied for about 1 1/2 years.

Among infectious diseases, tuberculosis is the second most common cause of adult deaths worldwide. The World Health Organization (WHO) estimates approximately one-third of the world’s population is infected with Mycobacterium tuberculosis and the disease is responsible for nearly 3,800 deaths per day, worldwide.

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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63

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