Viramune® (nevirapine) receives CHMP recommendation for approval
Publication date: 27 July 2011
Author: Boehringer Ingelheim
Tagged with: Boehringer Ingelheim, European Medicines Agency (EMA), Food and Drug Administration (FDA), Keikawus Arastéh, Klaus Dugi
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.
“Switching therapies can improve treatment adherence, which is often key to treatment success. With nevirapine prolonged-release, physicians and their patients can benefit from a simplified, once-daily treatment regimen while still maintaining the high level of efficacy, comparable tolerability, and the favourable lipid profile inherent to the nevirapine immediate release formulation,” commented Dr. Keikawus Arastéh, Director of Internal Medicine at Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany.
“Data has shown that the prolonged-release treatment option combines the trusted clinical benefits of nevirapine with the convenience of a single daily dose. Once approved in Europe, Viramune® prolonged-release will allow an easy switch for patients currently taking Viramune® twice-daily, and enable patients to be treated with a regimen that fits in with today’s prescribing trends,” added Professor Klaus Dugi, MD, Corporate Senior Vice President Medicine at Boehringer Ingelheim Headquarters.
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