TUBERCULOSIS: FDA Panel Recommends Accelerated Approval Of Bedaquiline, Janssen's Tuberculosis Drug
By RTT News, November 29, 2012,
(RTTNews.com) - Janssen Research & Development LLC, a subsidiary of Johnson & Johnson, announced that an FDA advisory panel on Wednesday voted unanimously (18-0) in support of the efficacy of its investigational drug Bedaquiline as an oral treatment to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis in adults.
The panel members voted 11-7 that the safety findings supported the approval of Bedaquiline for the proposed indication.
Bedaquiline is said to work by targeting adenosine triphosphate synthase, an enzyme that is required by the tuberculosis causing bacterium, Mycobacterium tuberculosis, to generate its energy.
Janssen submitted the Bedaquiline New Drug Application to the FDA based on a 24-week data from its phase II clinical development program on June 29, 2012, seeking accelerated approval. A confirmatory phase III trial of Bedaquiline is planned for 2013.
The Bedaquiline NDA has been assigned a priority review by the FDA with a decision date expected on December 29, 2012.
After service in the British SAS Regiment the author became a physician and then an orthopaedic surgeon.
He has held professorial positions in Canada, Vietnam and the United States, practiced and taught orthopaedic surgery in three continents and in several wars.
He has extensive experience as an expert witness in court. Somewhere along the way, time was found to operate a four hundred acre mixed farm, a one hundred seat restaurant and to obtain a licence as a flying instructor.
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