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news.The US Food and Drug Administration (FDA) has granted a Priority Review designation to Swedish pharmaceutical firm Medivir's supplemental New Drug Application (sNDA) for the use of once-daily Olysio (simeprevir) in combination with sofosbuvir for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C.
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The sNDA for Olysio and sofosbuvir was submitted in May by the company’s strategic partner Janssen Research & Development.
The regulatory submission is based on data from the phase II COSMOS trial which included treatment-naïve patients with advanced fibrosis (METAVIR F3 to F4 scores) and prior null-responder patients with all stages of liver fibrosis (METAVIR F0 to F4 scores).
Medivir EVP Development Charlotte Edenius said: "The Priority Review designation by the FDA shows the high priority and great importance of making interferon-free treatment regiments available to the many difficult to cure hepatitis C patients groups."
Jointly developed by Janssen R&D Ireland and Medivir, the NS3/4A protease inhibitor ‘Olysio’ is indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.
Global clinical development of Olysio is carried out by Janssen, which also has exclusive, worldwide marketing rights, except in the Nordic countries.
The Swedish firm retains marketing rights for Olysio in the Nordic countries under the marketing authorization held by Janssen-Cilag International.
Following EMA approval, Olysio is expected to be available across a number of EU countries in conjunction with reimbursement, in the second half of 2014.