FDA places partial hold on Achillion's sovaprevir

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) said late Monday that FDA placed a partial clinical hold on sovaprevir after a Phase I drug-drug interaction trial showed sovaprevir plus ritonavir-boosted atazanavir led to elevations of alanine aminotransferase (ALT) levels in healthy volunteers. Achillion was up $0.18 to $8.36 on Monday, but the stock slipped $1.91 (23%) to $6.45 in early after-hours trading on the news. FDA requested data from two other drug-drug interaction studies and an integrated safety analysis of ongoing sovaprevir trials. Achillion said it expects to provide the requested data within about six weeks.

Achillion is continuing to enroll and treat treatment-naive patients with chronic HCV infection in the Phase II 007 trial evaluating an-all oral regimen of Achillion's ACH-3102 plus sovaprevir and ribavirin. The company said patients in the trial have received up to six weeks of treatment with no safety issues. ...