AEGiS-Reuters: FDA Asks for More Data on Needle-Free AIDS Drug

Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.

FDA Asks for More Data on Needle-Free AIDS Drug

Reuters NewMedia - November 24, 2005

LOS ANGELES - Roche Holding AG and Trimeris said on Wednesday that the U.S. Food and Drug Administration has asked for additional trial data before allowing them to market a needle-free injection device for use with their AIDS drug Fuzeon.

The companies said the FDA issued an "approvable letter," requesting additional information from an ongoing trial of the device, which is made by Bioject Medical Technologies Inc.

Data from the trial is expected in the second half of 2006, the companies said.

The needle-free injector disperses liquid medication beneath the skin. Fuzeon is currently approved for administration with a needle and syringe.

Shares of Trimeris, which fell 2.4 percent to close at $12.96 on Nasdaq, were higher at $13.12 in after hours trading.

051124
RE051131

Copyright © 2005 - Reuters, Ltd. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Contact Reuters.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2005. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .