Supplemental New Drug Application Submitted to FDA by Janssen
Share
Follow Us
The Editors at Hepatitis Central
July 22, 2014
Find out about Janssen’s goal for Olysio to be used once-daily in combination with Sovaldi.
ISSUE: JULY 2014
Janssen Submits Supplemental NDA For Olysio for Once-Daily Use In Combination With Sofosbuvir
On May 7, Janssen announced the submission of a Supplemental New Drug Application (sNDA) to the FDA for simeprevir (Olysio), an NS3/4A hepatitis C virus (HCV) protease inhibitor, in combination with the NS5B HCV polymerase inhibitor, sofosbuvir (Sovaldi, Gilead Sciences). Janssen is seeking regulatory approval of the combination for the treatment of HCV genotype 1 infection in treatment-naive patients with advanced liver fibrosis and in null responders with all stages of liver fibrosis.
Continue reading this entire article:
http://www.idse.net/ViewArticle.aspx?d=Hepatitis&d_id=213&i=July+2014&i_id=1086&a_id=27752
