Roche, Trimeris receive FDA approvable letter for use of Fuzeon with needle-free injection device

New York, Nov. 23 - Roche and Trimeris said the Food and Drug Administration has given an approvable letter to their request for inclusion of information about the Biojector 2000 needle-free injection device in the Fuzeon (enfuvirtide) labeling.

In its letter, the FDA 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 Fuzeon.

The Biojector 2000, made by Bioject Medical Technologies Inc., is a needle-free, CO2-powered injector that disperses liquid medication beneath the skin.

Fuzeon is the first and only entry inhibitor available for the treatment of HIV and is currently approved for administration with a needle and syringe.

Roche is a Basel, Switzerland, pharmaceutical company while Trimeris, Inc. is a Morrisville, N.C., biopharmaceutical company.

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