Johnson & Johnson and partner Medivir are celebrating after getting European approval for their hepatitis C drug Olysio.
Specifically, Olysio (simeprevir) has been granted marketing authorisation by the European Commission for the treatment of genotype 1 and 4 HCV. The most significant element of the approval is that the drug will be available as part of the very first 12 week, all-oral, once-daily, interferon-free combination along with Gilead Sciences’ huge-selling Sovaldi (sofosbuvir).
J&J’s Janssen unit noted that Olysio, an NS3/4A protease inhibitor, will be available across a number of European Union countries, depending on reimbursement, in the second half of 2014. It was approved in the USA in November but not for use with Sovaldi, although a filing for that combo was submitted to the Food and Drug Administration earlier this month.
Thomas Stark, medical director for Janssen EMEA said the approval is “a great milestone as it adds an important new treatment option for patients, demonstrating the continued role of triple therapy [for HCV”.
