Armed with only a set of mid-stage data on its experimental therapy for drug-resistant TB, J&J's Janssen has tossed its NDA to the FDA in search of an accelerated approval. And J&J believes it is on track to snag an OK for bedaquiline (TMC207) as part of a combo drug treatment, making it the first new TB treatment to be approved in four decades.
Paul Stoffels, the worldwide chairman of pharmaceuticals at J&J ($JNJ), says the world can't wait for the late-stage study, which is scheduled to start later this year. Among infectious diseases, TB is the world's number two killer of adults.
"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," said Stoffels in the company's release.
The drug is aimed right at adenosine triphosphate synthase, cutting off the energy flow Mycobacterium needs to trigger tuberculosis. J&J generated 24-week data from an open label trial as well as a randomized study in their Phase II program.
- here's the press release
- get the story from the AP