EU approval for Janssen hep C drug

Janssen has announced that it has received European Commission (EU) approval for its new hepatitis C therapy Olysio.

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.

The safety and efficacy of the new drug, when used alongside a number of other agents, was demonstrated by data from clinical trials.

Olysio is now expected to 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 that the EU approval was: “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”.