Actionable news
0
All posts from Actionable news
Actionable news in GILD: Gilead Sciences, Inc.,

European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV

FOSTER CITY, Calif., Apr 25, 2016 (BUSINESS WIRE) -- Gilead Sciences, Inc. GILD, +0.19% today announced that the European Commission has granted marketing authorization for two doses of Descovy [® ] (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection. Descovy is Gilead’s second TAF-based therapy to receive marketing authorization in the European Union.

Descovy [] is indicated in the European Union for the treatment of adults and adolescents (ages 12 years and older with body weight at least 35 kg) in combination with other HIV antiretroviral agents. The marketing authorization is based on a Phase 3 HIV clinical program evaluating F/TAF in combination with other antiretroviral agents in treatment naïve, virologically suppressed, renally impaired and adolescent patients. The marketing authorization allows for the marketing of Descovy in all 28 countries of the European Union.

“Treatment backbones, paired with a third agent, are a cornerstone for successful management of HIV. 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,” said Dr. José Arribas, Associate Professor of Medicine, Autonoma University School of Medicine, Madrid. “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.”

TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread [®] (tenofovir disoproxil fumarate; TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently...


More