Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV Treatment
–Potential New Backbone for Future HIV Therapy Combinations–
FOSTER CITY, Calif.- (BUSINESS WIRE)- Apr. 7, 2015 -
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.
TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.
“Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens.”
Today’s filing is Gilead’s second F/TAF-based NDA submitted to the FDA for review. In November 2014, Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 5, 2015. Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014.
The F/TAF NDA is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The NDA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as
E/C/F/TAF) among treatment-naïve adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.
The recommended dose of F/TAF is 200/25 mg; if it is used in combination with a protease inhibitor that is administered with either ritonavir or cobicistat, the recommended dose is 200/10 mg.
Additional F/TAF-based regimens for HIV treatment are currently in development. In December 2014, Gilead announced the expansion of its existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two new investigational once-daily single tablet regimens containing F/TAF. One combines F/TAF with Janssen’s rilpivirine. The other regimen contains F/TAF, cobicistat and Janssen’s darunavir.
Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.
F/TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
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. 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 possibility that the FDA and other regulatory authorities may not approve F/TAF, E/C/F/TAF and other F/TAF-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, F/TAF, E/C/F/TAF and other F/TAF-based regimens may never be successfully commercialized.
In addition, Gilead may be unable to file for regulatory approval for F/TAF with other regulatory authorities in the currently anticipated timelines. 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 Annual Report on Form 10-K for the year ended December 31, 2014 , 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.
U.S. full prescribing information for Viread and Stribild, including BOXED WARNINGS , is available at www.gilead.com.
Viread and Stribild are registered trademarks of Gilead Sciences, Inc. , or its related companies.
For more information on Gilead Sciences , please visit the companyâ€™s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Ryan McKeel, 650-377-3548 (Media)
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