Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (≥ 12 years and ≥ 35 kg body weight). The data included in the application support the use of TAF in treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection.
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 European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.
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.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
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 European Commission or other regulatory agencies may not approve TAF for the treatment of chronic hepatitis B and that any marketing approvals, if granted, may have significant limitations on its use. As a result, Gilead may not be able to successfully commercialize TAF for chronic hepatitis B. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
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 Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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Last updated on: 11/11/2016
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