Fuzeon needle-free sNDA not trouble-free
This article was originally published in Pharmaceutical Approvals Monthly
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)...
You may also be interested in...
Fuzeon With Needle-Free Delivery To Be Resubmitted In Latter Half Of 2006
Trimeris expects to submit a response to FDA in the second half of 2006 following receipt of an "approvable" letter for use of its fusion inhibitor Fuzeon with a needle-free injection system
EU’s SCCS Finds Endocrine-Disrupting Evidence Inconclusive In UV Filter Reassessments
While endocrine-disrupting evidence was inconclusive, the Scientific Committee on Consumer Safety recommends more conservative limits on use of homosalate, octocrylene and benzophenone-3 in cosmetic products compared with current requirements under the European Cosmetics Product Regulation.
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: