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news.Janssen Research & Development company has submitted bedaquiline (TMC207) new drug application (NDA) to the US Food and Drug Administration (FDA) for approval.
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Bedaquiline,an investigational drug administered orally,is used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.
The submission for FDA’s approval is based on a 24-week trial data from the Phase II clinical development studies that includes an open-label study and a controlled, randomised trial that studied the efficacy and safety of bedaquiline versus placebo in the treatment of tuberculosis patients.
Janssen’s infectious diseases therapeutic area head Wim Parys was quoted by PharmaLive as saying,"it 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 multi-drug resistant TB.”
Bedaquiline, discovered by Janssen scientists, targets adenosine triphosphate (ATP) synthase, which Mycobacterium tuberculosis (M.tb)requires to create its energy.