Sovaprevir: FDA hold

Achillion said FDA will not lift a partial clinical hold on HCV compound sovaprevir. In June, FDA placed the hold after a Phase I drug-drug interaction trial showed that sovaprevir plus ritonavir-boosted atazanavir led to elevations of alanine aminotransferase (ALT) levels in healthy volunteers. Achillion said FDA indicated in its response that the company addressed all issues noted in the agency's June letter, but FDA still concluded that the removal of the clinical hold was "not warranted." The company could not be reached for details (see BioCentury, July 15).

In June, FDA had requested data from 2 other drug-drug interaction studies and an integrated safety analysis of ongoing sovaprevir trials. FDA had allowed continued enrollment and treatment of patients in the 12-week, international Phase II 007 trial evaluating an-all oral regimen of Achillion's ACH-3102 plus sovaprevir and ribavirin in treatment-naive patients with chronic HCV infection. Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) markets Reyataz atazanavir. ...