February 26, 2016
European CHMP Adopts Positive Opinion for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine/Tenofovir Alafenamide) for the Treatment of HIV
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 than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
The CHMP’s recommendation will now be reviewed by the
The MAA for Descovy is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. In the studies, the F/TAF-based regimen demonstrated statistically significant improvements in surrogate laboratory markers of renal and bone safety as compared to the F/TDF-based regimen. The MAA is also supported by data from an additional Phase 3 study evaluating Descovy among virologically suppressed adults who switched regimens (Study 1089), and studies evaluating the F/TAF-based regimen (administered as Genvoya) among adults with mild-to-moderate renal impairment and among adolescents. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of Descovy achieved the same drug levels of TAF and emtricitabine in the blood as in Genvoya.
Descovy is an investigational product and its efficacy and safety have
yet not been established in the
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that Descovy may not be approved by the
The European SmPCs for Genvoya, Stribild and Viread are available from the EMA website at www.ema.europa.eu.
Descovy, Genvoya, Stribild and Viread are registered trademarks of
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20160226005413/en/
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Ryan McKeel, +1 650-377-3548 (U.S.)
Stephen Head, +44 (0)7768 705945 (EU)