Executive Summary

Roche and Trimeris expect their response to a November 2005 "approvable" letter for needle-free administration of the HIV fusion inhibitor Fuzeon (enfuvirtide) "will be delayed until at least the first half of 2007," the companies announce Oct. 11. The sponsors had originally projected a second-half 2006 resubmission of the sNDA, which seeks to add information to labeling regarding Fuzeon's use with the Biojector 2000 device (1Pharmaceutical Approvals Monthly February 2006, p. 17). While FDA acknowledged in recent discussions that bioavailability was comparable between conventional Fuzeon and the needle-free delivery method, Roche/Trimeris said the agency expressed concern about hematomas and nerve pain seen with the Biojector device. As a result, FDA is requesting additional safety information, including data from the Fuzeon BOSS trial (Biojector Open Label Safety Study)...