The FDA has granted Janssen Research & Development priority review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.
The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to complete its review within six months of the NDA submission. The NDA was submitted June 29, 2012.
“There is a growing public health need for new treatment options for multi-drug resistant tuberculosis. If approved, bedaquiline would offer the first in a new class of anti-tuberculosis drugs for patients suffering from this serious and deadly disease,” said Wim Parys, M.D., head of the infectious diseases therapeutics, Janssen. “We are working closely with the FDA and other regulatory agencies in high-burden countries to quickly bring bedaquiline to the patients who need it.”
The regulatory submission was supported by 24-week data from the phase II clinical development program, which includes an open-label study and a controlled, randomized trial that evaluated the safety and efficacy of bedaquiline versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen.