FDA Panel Recommends Accelerated Approval Of Janssen's Tuberculosis Drug

JNJ 112912

Janssen Research & Development LLC, a subsidiary of Johnson & Johnson (JNJ), 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.

JNJ closed Wednesday's trading at $69.29, up 0.70% on a volume of 9.98 million shares.

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