BioCentury
ARTICLE | Clinical News

FDA refuses to lift sovaprevir hold

September 28, 2013 1:00 AM UTC

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) fell $3.34 (46%) to $3.90 in early after-hours trading after it said late Friday that 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 the selective inhibitor of HCV NS3 protease 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. Achillion was off $0.15 to $7.24 on Friday.

In June, FDA had requested data from two 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) markets Reyataz atazanavir (see BioCentury, July 1). ...