EU withdraws marketing authorisation for Abbvie's hepatitis C drug

Reuters

October 1, 2024 at 12:02 p.m.·1 min read

A woman holds a test tube in front of displayed Abbvie logo in this illustration

(Reuters) -The European Medicines Agency said on Tuesday that it has withdrawn the marketing authorisation for Abbvie's hepatitis C drug Exviera at the request of the company.

The regulator said it withdrew the authorisation on Sept. 25. It added that the authorisation holder, AbbVie Deutschland GmbH & Co. KG, had informed the European Commission of its decision to "permanently discontinue the marketing of the product for commercial reasons."

Abbvie did not immediately respond to a Reuters request for comment.

The drug, also known as dasabuvir, was granted authorisation in the European Union in January 2015 for the treatment of chronic hepatitis C, a liver disease caused by a bloodborne virus.

The authorisation for the drug was valid for an initial five-year period, and was extended indefinitely in 2019.

About 1.8 million individuals in the European Union countries are chronically infected with the hepatitis C virus, according to latest data from the European Centre for Disease Prevention and Control.

Current treatment options for patients include antiviral medications like Harvoni, Epclusa and Sovaldi - all three belonging to Gilead Sciences.

(Reporting by Bhanvi Satija and Mariam Sunny in Bengaluru; Editing by Shailesh Kuber)

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