EU approval for Gilead’s HIV combo Genvoya
pharmafile | December 1, 2015 | News story | Manufacturing and Production, Sales and Marketing | European Commission, Genvoya, Gilead, Gilead Sciences, HIV, TDF, World Aids Day, european union, taf
Gilead Sciences has won marketing authorisation from the European Commission (EC) for the once-daily single tablet regimen Genvoya as an HIV-1 infection treatment.
Genvoya (elvitegravir/cobicistat, emtricitabine and tenofovir alafenamide fumarate, or TAF) is now recommended in the European Union (EU) for the treatment of adults and adolescents (who are aged 12 years and older with body weight at least 35 kg) with HIV-1.
The combination therapy is the first TAF-based regimen to receive marketing authorisation in the EU. TAF is a novel targeted prodrug of tenofovir that has demonstrated similar efficacy similar at a lower dose than Gilead’s Viread (tenofovir disoproxil fumarate, TDF). Data show that because TAF enters HIV-infected cells more efficiently than TDF, it can be given at a lower dose, resulting in 91% less tenofovir in the bloodstream.
The EC granted approval to Genvoya based on one of the largest Phase III HIV clinical programmes conducted to date, studying more than 3,500 patients with HIV across 21 countries, including patients that have not had treatment, those who are virologically suppressed or renally impaired, and adolescent patients.
The marketing authorisation is also supported by 48-week data from two ongoing Phase 3 studies of 1,733 treatment-naïve adults, in which Genvoya has met its primary endpoint of non-inferiority compared to Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg), which is also produced by Gilead.
“For more than 25 years, Gilead has continually worked to develop new treatments to improve the management of HIV,” comments Norbert Bischofberger, Gilead’s executive vice president of research and development and chief scientific officer. “This has the potential to deliver long-term health benefits to people living with HIV.”
“With access to appropriate treatment, HIV patients today have the potential to live nearly as long as the general population. However, research shows they are at an increased risk of age- and treatment-related comorbidities, which means helping preserve long-term health should be a priority when making treatment decisions,” says Anton Pozniak, HIV service director at the Chelsea and Westminster Hospital in London.
“With this product, we have an important new treatment option for a range of HIV patients as it offers both demonstrated sustained viral suppression and improvements in certain renal and bone safety markers compared to TDF-based regimens.”
The EC approval came just in advance of World Aids Day 2015 (December 1), led by the National Aids Trust (NAT), to raise awareness of HIV and AIDS and reduced the stigma associated with the disease.
Genvoya was approved by the US FDA for the treatment of HIV-1 on November 5.
Joel Levy
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