Sovaprevir: FDA hold

Achillion said FDA lifted a partial clinical hold on HCV compound sovaprevir. The company can now evaluate sovaprevir at a maximum dose of 200 mg once daily in HCV patients and in single dose trials in healthy volunteers. FDA is maintaining a partial clinical hold for multiple dose trials in healthy volunteers. The company declined to disclose further details. FDA placed the hold on the compound last June after a Phase I drug-drug interaction trial showed sovaprevir plus ritonavir-boosted atazanavir led to elevations of liver enzymes in healthy volunteers (see BioCentury, July 15, 2013). ...