EU grants approval for Gilead’s HIV treatment Descovy
pharmafile | April 26, 2016 | News story | Manufacturing and Production, Research and Development | EU, HIV, approval, descovy, taf
Gilead Sciences (NASDAQ: GILD) has announced that the fixed-dose combination HIV treatment, Descovy (emtricitabine, tenofovir alafenamide), has been granted marketing authorisation by the European Commission.
The company’s second TAF-based therapy to receive EU authorisation has been indicated for the treatment of adults and adolescents in combination with other HIV antiretroviral agents. This authorisation allows for the marketing of the drug in all 28 countries of the EU. Descovy was also recently approved by the FDA.
This authorisation is supported by a plethora of Phase III data evaluating the safety and efficacy of of Descovy over a period of time. TAF-based regimens, like Descovy, proved superior to the likes of TDF therapy, Viread, in these trials. Furthermore, this drug demonstrated efficacy similar to and at a dose less than one tenth of Gilead’s Viread.
Norbert Bischofberger, executive VP of R&D at Gilead, comments: “We look forward to making Descovy available as quickly as possible throughout the European Union as we continue to advance a pipeline of HIV regimens that contain TAF.”
Dr José Arribas, associate professor of medicine at Autonoma University School of Medicine in Madrid, says: “Descovy is the first new HIV backbone approved in Europe in more than a decade and represents an important advance in addressing the needs of patients. The components of Descovy, either as part of a single or multi tablet regimen, offer physicians and their patients a simple and effective combination with improvements in renal and bone lab safety parameters.”
Sean Murray
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