Janssen Research & Development, LLC (Janssen) today announced that the Anti-Infective Drugs Advisory





Janssen Research & Development, LLC (Janssen) today announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0), agreed that the efficacy findings for investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a vote of 11-7 that the safety findings supported the proposed indication. “We are pleased with the committee’s recommendation and look forward to working with the FDA to bring this important therapy to patients who suffer from MDR-TB,” said Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen. “The positive recommendation from the FDA advisory committee is an important step toward achieving that goal.” The FDA assigned a Priority Review designation to the New Drug Application (NDA) filed by Janssen in June seeking accelerated approval for bedaquiline. Recommendations and findings from the advisory committee will be considered by the FDA in its review of the NDA for bedaquiline, but the FDA is not bound to follow them. About the clinical development program The regulatory submission is supported by 24-week data from the Phase 2 clinical development program. Bedaquiline was evaluated in two Phase 2 studies in patients with MDR-TB. TMC207-C208 was designed with two independent stages. Stage 1 was a controlled, randomized, exploratory trial in which 47 patients were treated for eight weeks with either bedaquiline or placebo in combination with a standardized background regimen for MDR-TB. In Stage 2, a controlled and randomized superiority trial, 160 patients were treated with either bedaquiline (400 mg once daily for two weeks followed by 200 mg three times a week for 22 weeks) or placebo in combination with a standardized background regimen for MDR-TB. Background therapy was continued for an additional 12 to 18 months. The primary endpoint was time to culture conversion. A second single-arm, open-label, Phase 2 study, TMC207-C209, enrolled 233 patients from 11 countries to evaluate the efficacy, safety and tolerability of  bedaquiline in the treatment of MDR-TB. Bedaquiline was dosed 400 mg once daily for two weeks followed by 200 mg three times weekly for 22 weeks in combination with an individualized background regimen for MDR-TB, followed by continued administration of the background regimen for 12 to18 months. A confirmatory Phase 3 trial, TMC207-C210, is planned for 2013. It is designed as a double-blind study comparing nine months of treatment with bedaquiline versus placebo (both with a background regimen). About Janssen Research & Development, LLC Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com. Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.