FDA issues approvable letter for Bioject needle-free injection device

On 23 November, Roche and Trimeris announced that hey had received an approval letter from the U.S. Food and Drug Administration (FDA), in response to their request for inclusion of information about the Biojector® 2000 (B2000) needle-free injection device in the T-20 (enfuvirtide, Fuzeon) labeling.

In the approval letter, the FDA has requested additional information from the ongoing ENF-404 or WAND (With A Needle-Free Device) study, a randomized, open-label, two-way, cross-over study assessing the tolerability of the B2000 device for administration of T-20.

The B2000, made by Bioject Medical Technologies Inc., is a needle-free, CO2-powered injector that disperses liquid medication beneath the skin. T-20 is the first and only entry inhibitor available for the treatment of HIV and is currently approved for administration with a needle and syringe.