The European Commission has approved a second interferon-free hepatitis C treatment regimen this year, granting marketing authorisation to Johnson & Johnson’s Olysio.
The drug is to be marketed by J&J’s subsidiary Janssen-Cilag and is approved for use alongside Gilead Sciences’ Sovaldi (sofosbuvir), which was authorised in the region in January this year to treat hepatitis C.
The approval for Olysio (simeprevir) covers its use in combination with Sovaldi, with or without ribavirin, in the treatment of people with hepatitis C genotype 1 or 4, regardless of prior treatment history.
This indication means the drug is part of the first ever 12-week all-oral therapy for people with hepatitis C.
Olysio is also approved as part of a 24-week combination therapy alongside Sovaldi, pegylated interferon (PegIFN) and ribavirin in treatment-naïve and prior relapse patients with genotype 1 or 4 with or without cirrhosis and patients with HIV. This combination is also recommend over a 48 week course of treatment in certain other patients.
This differs from Sovaldi’s approval in January when it became part of the first all-oral treatment available in the EU for people with chronic hepatitis C. It can be used alongside ribavirin in patients with hepatitis C genotypes 2 or 3 or those awaiting a liver transplant.
Olysio is already approved in other regions, including Japan, the US, Canada and Russia.
Janssen said that it now expects the drug to be available across a number of EU countries in the second half of 2014, depending on reimbursement decisions.
Thomas Stark, medical director at Janssen EMEA, said:“The EC marketing authorisation for simeprevir is a great milestone as it adds an important new treatment option for patients, demonstrating the continued role of triple therapy in the treatment of HCV.”