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Achillion’s HCV Drug Receives Fast Track Designation

Achillion Pharmaceuticals, a biopharmaceutical company based in New Haven, CT, reported in January that one of its hepatitis C virus (HCV) therapies in development has been granted fast track designation by the U.S. Food and Drug Administration (FDA). The drug, ACH-1625, is a protease inhibitor (PI) that stops the progression of hepatitis C virus (HCV) by preventing the replication of viral enzymes. PIs represent the first new class of HCV drugs in 10 years. ACH-1625 is currently in mid-stage clinical testing.


So called “fast tracking” expedites the review of drugs targeted to treat serious diseases, particularly if they help fulfill the unmet medical needs of patients.ACH-1625 is an oral medication taken once daily. In clinical trials it has been shown to be equally effective in treating patients with HCV genotypes 1a and 1b and was well tolerated.


“We are very pleased with the granting of a Fast Track designation for ACH-1625, which we believe highlights this protease inhibitor’s attributes, which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV,” said Michael Kishbauch, President and Chief Executive Officer of Achillion. “As we work toward achieving our near-term milestones, we remain eager to initiate an interferon-free, all-oral combination clinical study evaluating our protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of this year.”


Source: January 4, 2012