Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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

Roche/Genentech Keeps Commitment To External Cancer Innovation

Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.

US FDA Eases Changes For Certain Sterile Injectable Container Closure Materials

To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts