XTL Biopharmaceuticals (LSE: XTL) today announced that it has received "fast track" designation from the US Food and Drug Administration for XTL-6865 (formerly known as HepeX-C).
Fast track designation is granted to facilitate the development and expedite the regulatory review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs.
XTL-6865 is being developed to prevent hepatitis C (HCV) re-infection following a liver transplant and for the treatment of chronic HCV disease.
The fast track designation was limited by the FDA to the post-transplant indication.
XTL Biopharmaceuticals interim non-executive chairman Michael Weiss said, “The designation of XTL-6865 as a fast track program recognizes the need for new forms of treatment for patients with recurrent HCV following a liver transplant.”
XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and Ab65) against the hepatitis C virus E2 envelope protein. A single antibody version of this product was tested in a pilot clinical program that included both Phase I and Phase II clinical trials. In April 2005, XTL Biopharmaceuticals submitted a US investigational new drug application (IND) to the FDA in order to commence a Phase Ia/Ib clinical trial later this year for XTL-6865, the dual-monoclonal antibodies (mAb) product.
A biologics license application (BLA) is submitted before a drug is approved for marketing by the FDA. XTL Biopharmaceuticals noted that fast track designation gives it the opportunity to submit a BLA for XTL-6865 in sequential sections, and to have these sections reviewed as they are submitted. Fast track designation also opens the possibility for receiving a priority review or accelerated approval of the BLA where the review time at the FDA would be six months, further reducing the time to market.
Published by Globes [online], Israel business news - www.globes.co.il - on Monday, July 18, 2005