29 Nov 2012, BioSpectrum Bureau , BioSpectrum
Singapore: The Anti-Infective Drugs Advisory Committee of US FDA has voted for the efficacy findings for investigational bedaquiline, 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 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 Mr Wim Parys, global head of development, infectious diseases and vaccines, Janssen R&D. "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.
The regulatory submission is supported by 24-week data from the phase II clinical development program. Bedaquiline was evaluated in two phase II studies in patients with MDR-TB. TMC207-C208 was designed with two independent stages. Stage I 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 II, 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.
A second single-arm, open-label, phase II 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-to-18 months.