GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated have received marketing approval from the European Commission for Telzir (fosamprenavir) for the treatment of HIV infection in adults in combination with other anti-HIV medications, a release from Vertex said.
Protease inhibitors act by inhibiting the HIV-1 protease enzyme leading to the formation of immature virus and preventing the infection of new cells. Telzir was co-discovered by GSK and Vertex Pharmaceuticals.
When combined with other antiretroviral drugs, Telzir has demonstrated its ability to reduce the concentrations of HIV in plasma in both antiretroviral treatment-naive and experienced patients. Telzir with low-dose ritonavir offers a low pill burden (4 tablets per day), good tolerability, and may be dosed with or without food and water, which may facilitate HIV-infected patients' long-term adherence to therapy, the release says.
"The European approval of Telzir is good news as it gives clinicians and HIV-infected patients a simpler and well-tolerated treatment option," commented Lynn Marks, senior vice president of Infectious Diseases at GSK. "Today's approval is supported by an extensive clinical trial programme. Recent interim 96-week data for Telzir demonstrated sustained viral suppression, improved immunological status and a lack of protease resistance mutations in previously treatment-naïve patients receiving Telzir boosted with ritonavir," he added.
"Telzir's potency, tolerability, and convenience profile make it an excellent choice for protease inhibitor-based combination therapy," said Tony Coles, senior vice president of Commercial Operations at Vertex. "The approval of Telzir in the European Union marks an important step in bringing HIV patients new, state-of-the art treatment options. Our eleven-year collaboration with GlaxoSmithKline in the area of HIV protease inhibitors has been highly productive, and we look forward to continuing to deliver innovation to HIV patients and their physicians," he continued.
More than 1,200 people - both treatment-naive and PI-experienced patients - participated in clinical studies to test the safety and efficacy of Telzir with and without ritonavir. In all trials, study drugs were taken as part of combination therapy that included two nucleoside reverse transcriptase inhibitors.