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AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs

AbbVie Inc.' s ABBV shares plunged 10.3% after the FDA came up with a warning related to a couple of hepatitis C virus (HCV) drugs in the company's portfolio - Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, mostly in patients suffering from underlying advanced liver disease.

The regulatory body has therefore instructed the company to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.

Post-marketing reports of hepatic decompensation and hepatic failure in patients with underlying liver cirrhosis who were on HCV medicines led to the warning. Some of the cases resulted in liver transplantation or death, which were mostly reported in patients taking Viekira Pak who had evidence of advanced cirrhosis even before beginning treatment.

AbbVie has updated the U.S. Product Inserts (USPI) for Viekira Pak and Technivie from "not recommended in Child Pugh B patients" to a contraindication in patients with Child-Pugh B cirrhosis. However, patients classified as Child-Pugh C will remain contraindicated as they have been since approval. The updated USPI for Viekira Pak also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.

AbbVie intends to issue a Dear Health Care Provider letter to inform U.S. healthcare providers about the updates.

While the label update news comes as a disappointment for AbbVie, we note that Gilead Sciences Inc.'s GILD shares were up 5.8% on the news. The company has two HCV drugs, Sovaldi and Harvoni, on the market. Meanwhile, competition in the HCV market is intensifying as several companies including Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.

AbbVie is a Zacks Rank #2 (Buy) stock. Another favorably ranked stock in the health care sector is AstraZeneca plc AZN , carrying a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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