November 11, 2016
European CHMP Adopts Positive Opinion for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection
-- Vemlidy Demonstrated Similar Efficacy with Improvements in Renal and Bone Laboratory Safety Parameters Compared to Viread in Phase 3 Studies --
TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at one-tenth the dose of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, TAF improved certain renal and bone laboratory safety parameters compared to TDF in clinical trials.
The CHMP’s recommendation will now be reviewed by the
The MAA for TAF includes data from two international Phase 3 studies (Studies 108 and 110) in 1,298 treatment-naïve and treatment-experienced patients with HBV infection. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. The full data from Studies 108 and 110 were presented at the International Liver Congress™ (ILC) earlier this year.
TAF as a single-agent for HBV is an investigational product and its safety and efficacy have not yet been established.
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 the
Please refer to the Viread individual Summary of Product Characteristics for full prescribing information.
Any suspected adverse reactions to Viread should be reported to Gilead via email to safety_FC@gilead.com or by telephone +44 (0) 1223 897500.
The European SmPC for Viread is available from the EMA website at www.ema.europa.eu
Vemlidy and Viread are registered trademarks of
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20161111005286/en/
Gilead Sciences, Inc.
Sung Lee, +1-650-524-7792
Kelsey Grossman, +1-650-378-2103