News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Medivir AB (MVRBF): FDA Has Granted Priority Review For OLYSIO® In Combination With Sofosbuvir Supplementary New Drug Application


7/15/2014 8:19:07 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

Medivir AB (OMX: MVIR) announces that the Food and Drug Administration (FDA) has assigned a Priority Review designation to the 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. The sNDA was filed in May by Medivir’s strategic partner Janssen Research & Development LLC.

The regulatory submission for Olysio and sofosbuvir is supported by data from the phase II COSMOS study 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).

Help employers find you! Check out all the jobs and post your resume.

Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES