Schrodinger’s Candidate? Achillion’s Sovaprevir On Clinical Hold, But Phase II Combo Trial Continues
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Following findings of elevated liver enzymes in a Phase I drug/drug interaction study, FDA placed Achillion’s protease inhibitor sovaprevir on clinical hold. But the agency is allowing an ongoing Phase II combination trial with NS5A inhibitor ACH-3102 in HCV to continue, probably due in part to clean safety reads from other DDI studies with the protease inhibitor.