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Janssen receives EU approval for hepatitis C drug Olysio
Janssen has announced that its new hepatitis C therapy Olysio has been approved by the European Commission.
The regulatory body has ratified the simeprevir-based therapy for the treatment of adults with genotype 1 and 4 chronic hepatitis C, in combination with other medicinal products such as sofosbuvir, pegylated interferon and ribavirin.
Data from clinical trials has demonstrated the safety and efficacy of the new drug when used alongside a number of other agents.
It is now anticipated that Olysio will be available across a number of EU countries, in conjunction with reimbursement schemes, in the second half of 2014.
Thomas Stark, medical director for Janssen in the Europe, Middle East and Africa region, said this approval represents "a great milestone, as it adds an important new treatment option for patients, demonstrating the continued role of triple therapy in the treatment of hepatitis C virus".
This comes after the firm received EU approval for Vokanamet, a new combination therapy for type 2 diabetes, last month.
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