April 21, 2014
Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA
-- Final FDA Decisions Anticipated by October 3 and 4, 2014 --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 21, 2014--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food
and Drug Administration (FDA) has accepted the company’s refiling of two
New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or
“boosting” agent that increases blood levels of the protease inhibitors
atazanavir and darunavir to enable once-daily dosing of these medicines
in HIV therapy, and elvitegravir, an integrase inhibitor for the
treatment of HIV-1 infection in treatment-experienced adults. The FDA
has set target review dates under the Prescription Drug User Fee Act
(PDUFA) of October 3, 2014 for cobicistat and October 4, 2014 for
Gilead submitted NDAs for cobicistat and elvitegravir in June 2012. In
April 2013, the company received Complete Response Letters from the FDA.
In its communications, the agency stated that it could not approve the
cobicistat and elvitegravir applications in their current forms, citing
deficiencies in documentation and validation of certain quality testing
procedures and methods that were observed during inspections. Gilead has
worked with the FDA to address the questions raised in the Complete
Cobicistat and elvitegravir are components of Gilead’s Stribild®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg), a once-daily single tablet regimen for the
treatment of HIV-1 infection. Stribild was approved in the United States
in August 2012.
Cobicistat is approved under the tradename Tybost® and
elvitegravir is approved under the tradename Vitekta® in
Europe, Canada and Australia.
About Cobicistat and Elvitegravir
Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor. It boosts blood
levels of the HIV protease inhibitors atazanavir and darunavir by
suppressing CYP3A, an enzyme that metabolizes these drugs in the body.
Cobicistat acts only as a pharmacokinetic enhancer and has no antiviral
Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in
March 2005. Under the terms of Gilead’s agreement with JT, Gilead has
exclusive rights to develop and commercialize elvitegravir as a single
agent in all countries of the world, excluding Japan, where JT retains
Cobicistat and elvitegravir are investigational products in the United
States and their 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. Headquartered in Foster City,
California, Gilead has operations in North and South
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 risks
related to the fact that the FDA may not approve elvitegravir or
cobicistat in the currently anticipated timelines or at all. In
addition, any marketing approvals, if granted, may have significant
limitations on their use. Further, the FDA may not be satisfied with the
responses Gilead provided in connection with the Complete Response
Letters. 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, 2013, 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 Tybost and Vitekta are
available at http://www.ema.europa.eu.
U.S. full prescribing information for Stribild is available at www.gilead.com.
Tybost, Stribild and Vitekta are registered trademarks of Gilead
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Miller, 650-522-1616 (Media)