FDA Advisory Committee Recommends Accelerated Approval of Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline
RARITAN, N.J., Nov. 28, 2012 /PRNewswire/ -- 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.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of healthcare products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Research & Development, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments).
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SOURCE Janssen Research & Development, LLC