The European Commission (EC) has granted marketing authorisation to biopharmaceutical company Gilead Sciences, for two doses of Descovy (emtricitabine and tenofovir alafenamide 200/10mg and 200/25mg; F/TAF).
Along with other HIV antiretroviral agents, Descovy is used to treat adults as well as adolescents who are aged 12 and above with a body weight of at least 35kg.
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This is a fixed-dose combination that is used to treat patients afflicted with HIV-1 infection.
Descovy is the company’s second TAF-based therapy that has received marketing authorisation in the European Union.
The marketing authorisation is based on a Phase III HIV clinical programme that evaluates F/TAF in combination with other anti-retroviral agents in adult and adolescent patients.
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Having received the authorisation, Gilead Sciences will now be able to market Descovy in all 28 countries of the European Union.
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By GlobalDataGilead Sciences chief scientific officer and research and development executive vice-president Norbert Bischofberger said: "TAF represents the latest development in Gilead’s more than 25-year history of innovation in the field of HIV, and we are pleased to offer patients and physicians another TAF-based therapy that expands their treatment options.
"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."
The marketing authorisation is supported by a 48-week data from a Phase III study, which analyses the safety and efficacy of switching virologically suppressed HIV-1 infected adult patients from regimens containing emtricitabine and tenofovir disoproxil fumarate (F/TDF), plus a third agent to regimens containing F/TAF with the same third agent.
At the last week, the F/TAF-based regimens were discovered to be statistically non-inferior when compared to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies every mL.
The study additionally revealed statistically significant improvements in renal and bone laboratory parameters among patients receiving the F/TAF-based regimens.
The authorisation is also supported by a 48-week data from two major Phase III studies that analysed a Genvoya administered F/TAF-based regimen, elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg (E/C/F/TAF), against an F/TDF-based regimen administered as Stribild, elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (E/C/F/TDF) among adult patients.
In these studies, certain renal and bone laboratory parameters favoured the F/TAF-based regimen over the F/TDF-based regimen.
Additionally, it is supported by data from studies evaluating an F/TAF-based regimen among adults with mild-to-moderate renal impairment, and among treatment naive adolescents.
Finally, bioequivalence studies showed that the formulation of the fixed-dose combinations of Descovy attained the same drug levels of TAF and emtricitabine in the blood as Genvoya.
