Boehringer Ingelheim - Viramune (Nevirapine) Prolonged-Release Once-Daily Formulation for the treatment of HIV-1 infection receives approval in the EU
From ENP Newswire (September 22, 2011)
ENP Newswire - 22 September 2011
Release date- 21092011 - Ingelheim, Germany, - Boehringer Ingelheim announced today that once-daily Viramune (nevirapine) prolonged-release has received approval for use in the EU. 1
The new, prolonged-release tablet is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection.
EU approval for the use of one 400 mg tablet once daily for adults and adolescents - and for 50 mg and 100 mg 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. 2,3
The Viramune XR single 400 mg tablet once daily was approved in the USA by the Food and Drug Administration (FDA) 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, 2,3 with a safety and tolerability profile comparable to nevirapine IR.
Dr. Keikawus Arasteh, Director of Internal Medicine at Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany, commented: 'Nevirapine prolonged-release provides physicians and patients with a simplified, once-daily treatment while maintaining the high level of efficacy, comparable tolerability and favourable lipid profile already associated with the nevirapine immediate-release formulation.'
He added: 'Switching therapies and a low pill burden can improve treatment adherence, which is often key to treatment success.'
Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim Headquarters, stated: 'Data show that Viramune prolonged-release, combines the trusted clinical benefits of nevirapine with the convenience of a single tablet, once daily dose. Nevirapine prolonged-release allows an easy switch for patients currently taking nevirapine twice-daily.'
'Viramune prolonged-release tablets give patients a simplified treatment option without compromising on clinical efficacy and fits in with today's prescribing trends,' he added.
1.European Medicines Agency
2.Gathe J et al. Efficacy and safety of nevirapine extended- release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1 infected patients. Antiviral Therapy 2011;16 (epub ahead of print) 3.Arasteh K et al. 24 Wk Efficacy and Safety of Transitioning Virologically Stable HIV-1 Patients from IR Nevirapine 200 mg BID to Nevirapine XR 400 mg QD. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Boston, MA, USA, September 12-15, 2010: Poster: 207
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Posted: September 2011