J&J Submits sNDA for New Dosing Regime for Hepatitis C Drug
Janssen Therapeutics, Division of Janssen Products, LP, has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration () to update the label for once-daily, all-oral Olysio(simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, currently approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection. The drug is now approved as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by Gilead Sciences, Inc.
Olysio was approved in November 2014 in combination with sofosbuvir. This sNDA is based on results from Phase III trials, which evaluated 12 and eight weeks of therapy for treatment-naÃ¯ve and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naÃ¯ve and treatment-experienced genotype 1 CHC adult patients with cirrhosis.
Olysio is an NS3/4A protease inhibitor which wasn developed by Janssen Sciences Ireland UC in collaboration with Medivir AB. In November 2013, Olysio was initially approved by the FDA and in May 2014, it was granted marketing authorization by the European Commission. Subsequent marketing authorizations have followed in several other countries around the world. Indications vary by market. Janssen is responsible for the global clinical development of Olysio and has exclusive worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for Olysio in these countries under the marketing authorization held by Janssen-Cilag International NV.
Source: Johnson & Johnson