Priority review for Tibotec’s HIV drug etravine
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA grants priority review to Tibotec's NDA for etravine (TMC125), setting the review clock for a Jan. 18, 2008, user fee date. The non-nucleoside reverse transcriptase inhibitor was the first in the class to show antiviral activity in patients with documented NNRTI resistance, according to the Ortho Biotech subsidiary. The NDA is supported by two Phase III 24-week randomized, double-blinded, placebo-controlled trials - DUET-1 and DUET-2 - that compared the agent in combination with other antiretroviral agents in treatment-experienced HIV-1 patients. TMC125 is currently available through an expanded access program in the U.S., Europe and Canada for HIV-1 infected adults who have experience with each of three major oral classes of ARVs (NRTIs, NNRTIs and protease inhibitors), are unable to use currently approved NNRTIs due to resistance/intolerance and have received at least two PI-based regimens...