Viramune® (nevirapine) prolonged-release once-daily formulation for the treatment of HIV-1 infection receives CHMP recommendation for approval

Ingelheim, Germany, 27th July 2011 – Boehringer Ingelheim announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending the approval of once-daily Viramune® (nevirapine) prolonged-release in all member states of the European Union. ¹ The CHMP recommendation states that the new prolonged-release tablet is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection.

The CHMP recommendation — which includes the once-daily, one tablet 400 mg strength for adults and adolescents and the once-daily 50 mg and 100 mg strengths for children — follows clinical trial results confirming the significant therapeutic benefits of nevirapine when administered in a convenient once-a-day formulation. ^2,3

In the U.S.A., the Viramune® once-daily, one tablet 400 mg formulation was approved by the Food and Drug Administration (FDA) earlier this year.

In clinical trials, the antiviral efficacy of the new once-daily Viramune® prolonged-release 400mg tablet, was shown to be non-inferior to the twice-daily immediate-release 200mg tablet, ^2,3 with a safety and tolerability profile comparable to nevirapine immediate-release first approved in 1996.