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FDA Panel Recommends Accelerated Approval of Bedaquiline for Multidrug-Resistant Tuberculosis
NDA was filed in June (Nov. 28)
The Anti-Infective Drugs Advisory Committee of the FDA has voted unanimously (18-0) that the efficacy findings for the investigational diarylquinoline drug bedaquiline (formerly TMC207, Janssen) support the proposed indication for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The committee also agreed in a vote of 11-7 that the safety findings supported the proposed indication.
The FDA assigned a priority review designation to the New Drug Application (NDA) filed 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.
Bedaquiline was evaluated in two phase II studies in patients with MDR-TB. One of the studies (TMC207-C208) was designed with two independent stages. Stage 1 was a controlled, randomized, exploratory trial in which 47 patients were treated for 8 weeks with either bedaquiline or placebo in combination with a standardized background regimen for MDR-TB. In Stage 2 (a controlled, randomized superiority trial), 160 patients were treated with either bedaquiline (400 mg once daily for 2 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 II study (TMC207-C209) enrolled 233 patients to evaluate the efficacy, safety, and tolerability of bedaquiline in the treatment of MDR-TB. Bedaquiline was administered at a dosage of 400 mg once daily for 2 weeks followed by 200 mg three times weekly for 22 weeks in combination with an individualized background regimen for MDR-TB. The background regimen was administered for an additional 12 to18 months.
A confirmatory phase III trial (TMC207-C210) is planned for 2013. The double-blind study will compare 9 months of treatment with bedaquiline versus placebo, both administered with a background regimen.