Telaprevir Receives European Approval

September 21, 2011

September 21, 2011 — The executive branch of the European Union today approved the hepatitis C drug telaprevir just 4 months after the US Food and Drug Administration (FDA) gave its okay.

Telaprevir is a direct-acting antiviral protease inhibitor for the treatment of genotype-1 chronic hepatitis C virus infection in combination with peginterferon alfa and ribavirin.

In May, the pharmaceutical company Vertex received FDA approval to market telaprevir in the United States under the brand name Incivek for adults with compensated liver disease, including cirrhosis, who are treatment-naive or who have been previously treated with interferon-based treatment. Incivek-brand telaprevir also received approval in August from Health Canada.

Hepatitis C drug telaprevir (Incivo)

Today's decision by the European Commission will allow Janssen Pharmaceutical Companies to market telaprevir for adults under the brand name Incivo throughout the European Union. The drug was codeveloped by Janssen in collaboration with Vertex and Mitsubishi Tanabe Pharma.

A committee of the European Medicines Agency recommended European Commission approval of telaprevir in July, saying that adding the drug to peginterferon alfa and ribavirin "will significantly enhance the proportion of patients that could be cured of their hepatitis C." For some patients, it said, telaprevir will translate into a shorter course of treatment.

The FDA stated earlier this year that telaprevir may be able to reduce hepatitis C treatment, for most patients, from the standard 48 weeks to 24 weeks.

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