AbbVie In Hot Seat Over HCV Drugs' Serious Liver Injury Risk

After adverse event reports in patients with underlying advanced liver damage, FDA requires AbbVie to add risk language to Viekira Pak and Technivie labels. AbbVie may not see much long-term damage, but Merck likely will gain more traction when it enters the hepatitis C market.

FDA’s alert about liver failure and death in patients taking AbbVie Inc.’s hepatitis C fixed-dose combination therapies Viekira Pak and Technivie is a significant setback for a company already a distant second in the market, and clears the way for HCV newcomer Merck & Co. Inc.

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