В ЕС одобрен АРВ-препарат Descovy компании Gilead
Gilead Sciences has secured marketing authorization from the European Commission (EC) for its fixed-dose combination Descovy (emtricitabine, tenofovir alafenamide) to treat HIV-1 infection.
Descovy is indicated in the European Union (EU) to treat adults and adolescents aged 12 years and older with body weight at least 35 kg in combination with other HIV antiretroviral agents.
It is the company's second TAF-based therapy to secure marketing authorization in the EU.
The EC's approval was based on data from a Phase 3 study evaluating the safety and efficacy of switching virologically suppressed HIV-1 infected adult patients from regimens containing emtricitabine and tenofovir disoproxil fumarate (F/TDF; Truvada) and a third agent to regimens featuring F/TAF plus the similar third agent.
The F/TAF-based regimens were demonstrated to be statistically non-inferior to the F/TDF-based regimens, depending on percentages of patients with HIV-1 RNA levels less than 50 copies per mL.
Statistically significant improvements were also seen in renal and bone laboratory parameters among patients receiving the F/TAF-based regimens.
Data from two other pivotal phase 3 studies also supported the marketing authorization.
Gilead Sciences executive vice president of research and development and chief scientific officer 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."