FDA to review Achillion's HCV drug on fast track basis
Tuesday, May 15 2012 | Comments
Achillion Pharmaceuticals Inc.
received a fast track designation from the Food and Drug Administration
for ACH-3102 for use as part of an interferon-free regimen for the treatment of chronic hepatitis C virus (HCV).
The drug, a pangenotypic second-generation nonstructural (NS) 5A inhibitor against HCV, is in Phase I testing. Achillion noted that ACH-3102 demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies.
The firm sought fast track designation for the compound because of its potential for development in a once-daily, interferon-free, fixed-dose combination and its potential to provide improved safety in comparison with the current standard of care. Further, Achillion said ACH-3102 has the potential to deliver potent antiviral activity in vitro against HCV genotypes 1 through 6.
The investigational agent also has a low potential for drug-drug interactions, according to Achillion, and therefore could have greater potential to treat patients with HCV who have comorbidities and those who are co-infected with HIV. For that same reason, it could also prove beneficial in treating patients with HCV before and after they undergo liver transplantation.