Once daily Viramune set for approval in Europe
pharmafile | August 1, 2011 | News story | Sales and Marketing | Boehringer Ingelheim, HIV
European regulators have recommended the approval of a new, once-daily form of Boehringer Ingelheim’s HIV treatment Viramune.
Viramune (nevirapine) has been on the market since 1996 in a twice-daily, immediate-release 200mg tablet, but the new positive opinion from the CHMP concerns a one tablet 400 mg strength for adults and adolescents.
Once-daily 50 mg and 100 mg strengths for children are also included in the CHMP’s decision, which covers all countries in the European Union. The new formulation was approved in the US earlier this year.
“Data has shown that the prolonged-release treatment option combines the trusted clinical benefits of nevirapine with the convenience of a single daily dose,” says Klaus Dugi, Boehringer’s corporate senior vice president medicine.
“[It] 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,” Dugi added.
The non-nucleoside reverse transcriptase inhibitor (NNRTI) is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection. Several studies have demonstrated its prolonged suppression of HIV-RNA.
In the VERxVE and TRANxITION trials, the prolonged-release version of Viramune was also not inferior to the immediate-release formulation.
“Switching therapies can improve treatment adherence, which is often key to treatment success,” said Keikawus Arastéh, director of internal medicine at Vivantes Auguste-Viktoria-Klinikum in Berlin.
“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,” Arastéh added.
The biggest risk is of potentially life-threatening severe rash and hepatic events in the first six weeks of therapy, in which case Viramune treatment should be stopped.
Adam Hill
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