Roche and Trimeris have received an approvable letter from the US Food and Drug Administration, in response to their request for inclusion of information about the Biojector 2000 (B2000) needle-free injection device in the Fuzeon (enfuvirtide) labelling.
In the approvable letter, 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 Fuzeon, states a company release.
The B2000, 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 and Trimeris filed a supplemental new drug application (sNDA) in May 2005 based on data from the T20-405 study, a single-dose pharmacokinetic study of Fuzeon administered by a nurse via the B2000 needle-free device, compared to standard needle-syringe administration. In August 2005, Roche and Trimeris initiated the Fuzeon Wand (With A Needle-Free Device, or ENF-404) study, an eight-week trial designed to assess patient acceptance and experience of Fuzeon administration via the B2000 needle-free device compared to the standard needle and syringe. The primary endpoints of this study are tolerability and injection site reactions. This trial is currently enrolling and final data are expected in the second half of 2006.
The release further adds that Fuzeon is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, Fuzeon works outside the CD4 cell, blocking HIV from entering the cell.