Achillion Pharmaceuticals, Inc. (ACHN) announced the receipt of a fast track designation from the U.S. Food and Drug Administration, or FDA, for ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C, or HCV. ACH-3102 is a pan-genotypic second-generation NS5A inhibitor against HCV that was discovered by Achillion and is currently being evaluated in a Phase 1 clinical trial.
Fast Track designation was requested for ACH-3102 for its potential to provide - improved safety as compared to the current standard of care, potential for development in a once daily interferon-free fixed dose combination, potent antiviral activity in vitro against HCV genotypes 1 through 6 and low potential for drug-drug interactions and therefore greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre- or post-liver transplantation.
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