About My Health Careers Internship MedBlogs Contact us
Medindia LOGIN REGISTER
Advertisement

Trimeris and Roche Decided to Withdraw Supplemental Application To Market Fuzeon

by Medindia Content Team on October 6, 2007 at 8:29 PM
Font : A-A+

Trimeris and Roche Decided to Withdraw Supplemental Application To Market Fuzeon

On Wednesday, Trimeris, a N.C.-based pharmaceutical company and Roche, a Swiss pharmaceutical company stated they are withdrawing a supplemental application with FDA to sell a needle-free injection device for use with the HIV antiretroviral drug Fuzeon.

Trimeris and Roche in July 2005 applied to use Bioject Medical Technologies' Biojector 2000 injection system as a needle-free injection device for use with Fuzeon, which is currently administered with a needle. Fuzeon, a fusion inhibitor, is approved to treat HIV infection in combination with other antiretrovirals. About 10% of eligible U.S. HIV-positive patients were taking Fuzeon in 2005.

Advertisement

The companies said they decided to withdraw the application after an assessment of the clinical program, as well as a delay in FDA approval because of a request to produce more data, the AP/Houston Chronicle reports.

"While the device has shown potential benefit for some patients, we don't believe it's the ideal alternative delivery option for all treatment-experienced patients," Michelle Zupancic, a vice president at Roche, said, adding, "We continue to review other options for administering Fuzeon,".
Advertisement

The companies also said in a statement that they believe that "patients who are currently administering Fuzeon with the device through an existing program or clinical trial may continue to do so, provided that the precautions in the current Fuzeon label regarding use with B2000 are followed".

Source: Kaiser Family Foundation
LIN/V
Advertisement

Advertisement
News A-Z
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Advertisement
News Category
What's New on Medindia
Black Pepper as Preventive Measure Against Omicron
FODMAP Diet: A Beginner's Guide
Smallpox
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.


Recommended Reading
Clinical Trials
Clinical trials are experiments that yield useful information to clinicians if a particular ......
Daily Dose of Antiretroviral Drug Could Save Healthy People from HIV Infection
Providing healthy people with an antiretroviral drug to protect them against HIV infection could ......

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use