Enfuvirtide Makers No Longer Attempting to Market Their Drug with a Needle-Free Device

The makers of enfuvirtide (Roche and Trimeris, Inc.) have announced that they are withdrawing an FDA application that requested approval to market enfuvirtide with the Biojector 2000 needle-free injection device. The application was initially submitted in 2005, but the FDA delayed approval and requested more data, citing concerns about nerve pain and bruising. According to a press release from Roche and Trimeris, patients who are currently using the Biojector 2000 device to administer enfuvirtide can continue to do so, as long as they follow the precautions described in the current enfuvirtide label (ACC Feb 5 2007).