(Reuters) -The European Medicines Agency said on Tuesday that it has withdrawn the marketing authorisation for Abbvie’s hepatitis C drug Exviera at the request of the company.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(Reuters) -The European Medicines Agency said on Tuesday that it has withdrawn the marketing authorisation for Abbvie’s hepatitis C drug Exviera at the request of the company.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