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.
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.
Having received the authorisation, Gilead Sciences will now be able to market Descovy in all 28 countries of the European Union.
Gilead 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.