Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread® (tenofovir disoproxil fumarate). The first new indication permits the use of Viread in combination with other antiretroviral agents for the treatment of HIV-1 infected pediatric patients aged 2 to less than 18 years with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line pediatric agents. Additionally, Viread is now approved for the treatment of chronic hepatitis B virus (HBV) infection in adolescent patients aged 12 to less than 18 years with compensated liver disease and evidence of immune active disease. Today’s authorization covers all 27 countries of the European Union (EU). Viread was approved for use in combination with other antiretroviral agents as a treatment for HIV-1 infection in adults and for chronic HBV in 2002 and 2008, respectively, and is the most-prescribed molecule for these diseases in major European countries.
Today’s decision includes marketing authorization for a new oral granule formulation of Viread for HIV-1 infected children aged 2 to less than 6 years, and for HIV-1 infected children above 6 years of age for whom a solid dosage form is not appropriate. The agency also approved three new reduced-strength Viread tablets in doses of 123 mg, 163 mg and 204 mg for HIV-1 infected children aged 6 to less than 12 years. The use of the lower-strength tablets and the oral granule formulation are based on the patient’s age and weight.
The existing, full-strength 245 mg Viread tablet formulation is now available for use by adolescents aged 12 to less than 18 years to treat both HIV-1 infection and chronic HBV infection in those with compensated liver disease. For adolescents and adults for whom the 245 mg tablets are not appropriate, the oral granule formulation may be used.
“We are pleased to provide new therapeutic options for younger patients living with HIV and chronic hepatitis B and will work to make these pediatric formulations available as quickly as possible,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.
The new indications are supported by clinical data from three studies examining the use of Viread among children and adolescents with HIV and among adolescents with chronic HBV. The safety and efficacy of Viread has not been established in children less than 2 years of age for HIV treatment, or in children less than 12 years of age for the treatment of chronic HBV.
In an effort to accelerate the availability of pediatric formulations in low-income countries, where the majority of children with HIV live, Gilead has established incentives to encourage its Indian generic manufacturing partners to develop pediatric formulations of its HIV treatments. Through these partnerships, Gilead already makes Viread available at significantly reduced cost for adults living with HIV and chronic HBV in low-income countries.
EU Important Safety Product Information About Viread, Including Boxed Warnings
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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
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 healthcare providers may not see advantages of Viread for HIV-infected children and HBV-infected adolescents over other formulations and may therefore be reluctant to prescribe the product. 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, 2012, 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.
EU Summary of Product Characteristics for Viread is available at http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp
Viread is a registered trademark of Gilead Sciences, Inc.
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