October 5, 2007
Durham, N.C.-based pharmaceutical company Trimeris and Swiss pharmaceutical company Roche on Wednesday announced they are withdrawing a supplemental application with FDA to sell a needle-free injection device for use with the HIV antiretroviral drug Fuzeon, the Raleigh News & Observer reports (Vollmer, Raleigh News & Observer, 10/4).
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 (Kaiser Daily HIV/AIDS Report, 11/2/05).
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 (AP/Houston Chronicle, 10/3). "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," (Trimeris release, 10/3).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2007 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.