Boehringer once-daily AIDS drug Viramune cleared in EU
Independent German drug major Boehringer Ingelheim says that once-daily Viramune (nevirapine) prolonged-release has received approval for use in the European Union and is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection.
EU approval for the use of one 400mg tablet once daily for adults and adolescents - and for 50mg and 100mg strengths for once-daily treatment of children - is based on results from clinical trials confirming the significant therapeutic benefits of nevirapine when administered in a convenient once-a-day formulation.
The Viramune XR single 400mg tablet once daily was approved by the US Food and Drug Administration earlier this year. In clinical trials, the antiviral efficacy of Viramune prolonged-release tablets was shown to be non-inferior to the older, twice-daily immediate-release (IR) 200mg tablet, with a safety and tolerability profile comparable to nevirapine IR.
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