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.
The Viramune 400mg once-daily tablet was approved by the US Food and Drug Administration (FDA) earlier this year.