Trimeris, Roche Withdraw Supplemental Application To Market Needle-Free Device With Antiretroviral Fuzeon
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).
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" (AP/Houston Chronicle, 10/3).