Janssen Gets FDA Nod for Hepatitis C Combo with Gilead

Janssen Therapeutics, a division of Janssen Products, LP, has received US Food and Drug Administration (FDA) approval for Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

Olysio is jointly developed by Janssen R&D Ireland and Medivir AB, a Sweden-based pharmaceutical company, and is indicated for the treatment of CHC infection as a component of a combination antiviral treatment regimen. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. Simeprevir was approved in September 2013 in Japan, in November 2013 in Canada and the US, in March 2014 in Russia, and in July 2014 in Mexico and Australia. In May 2014 simeprevir was granted marketing authorization by the European Commission (indications vary by market).

Sofosbuvir, the active ingredient in Gilead’s Sovaldi, is Gilead’s top-selling drug. It had sales of $8.550 billion for the first nine months of 2014. It was approved by the US Food and Drug Administration in December 2013 as the first all-oral interferon-free regimen for treating CHC. It was approved as a component of a combination antiviral treatment regimen.

Source: Johnson & Johnson

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