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AbbVie, Enanta tumble on FDA warning for HCV regimens
October 23, 2015 1:53 AM UTC
AbbVie Inc. (NYSE:ABBV) shed $5.56 (10%) to $48.27 and Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) plummeted $16.35 (41%) to $23.90 on Thursday after FDA issued a safety warning linking HCV therapies Viekira Pak and Technivie to cases of serious liver injury in cirrhotic HCV patients and required AbbVie to add information regarding liver injury risks to both drugs' labels.
AbbVie told BioCentury the U.S. labels for Viekira and Technivie now include a contraindication for patients with decompensated cirrhosis Child-Pugh class B and C. The label previously did not recommend Viekira for patients with decompensated cirrhosis Child-Pugh class B and was contraindicated in class C. ...