Boehringer Ingelheim has received EU approval for its Viramune (nevirapine) prolonged-release once-daily formulation, indicated for the treatment of HIV-1 infection.
The approval is based on results from clinical trials that confirmed the therapeutic benefits of nevirapine when administered in a once-daily formulation.
The VERxVE trial evaluated the antiviral efficacy and safety of once-daily nevirapine 400mg compared to twice-daily nevirapine 200mg.
The TRANxITION trial examined the efficacy and safety of switching virologically suppressed patients from nevirapine immediate-release 200mg twice-daily to nevirapine prolonged-release 400mg once-daily.
The antiviral efficacy of Viramune prolonged-release tablets was found to be non-inferior to the older, twice-daily immediate-release 200mg tablet, with a comparable safety and tolerability profile.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
The Viramune 400mg once-daily tablet was approved by the US Food and Drug Administration (FDA) earlier this year.