The US Food and Drug Administration (FDA) has assigned the Fast Track designation to Achillion Pharmaceuticals, Inc.’s ACH-1625, a drug being tested for use against chronic hepatitis C virus (HCV) infection, the company announced January 4.
ACH-1625 is an HCV protease inhibitor discovered by Achillion. Unlike the approved protease inhibitors Victrelis (boceprevir) and Incivek (telaprevir), which require dosing every seven to nine hours, ACH-1625 only needs to be taken once a day. ACH-1625, currently in Phase II studies, also appears to be equipotent against HCV subtypes 1a and 1b.
The drug has been given Fast Track status for its potential to improve upon the current standard of care in a number of areas. These include greater safety and drug tolerance; a better drug interaction profile for patients requiring other medications (such as for HIV or liver transplant); and the possibility of interferon-free combination therapy.
The FDA’s Fast Track program is aimed at speeding the approval and release of drugs for serious medical conditions. Researchers of a Fast Track drug get to communicate more frequently with the FDA, and the drug is eligible for an accelerated review process.