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– Odefsey is the Smallest Single Tablet HIV Regimen –
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 1, 2016--
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food
and Drug Administration (FDA) has approved Odefsey®
(emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or
R/F/TAF) for the treatment of HIV-1 infection in certain patients.
Emtricitabine and tenofovir alafenamide are from Gilead Sciences and
rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is
Gilead’s second TAF-based regimen to receive FDA approval and represents
the smallest pill of any single tablet regimen for the treatment of HIV.
Odefsey is indicated as a complete regimen for the treatment of HIV-1
infection in patients 12 years of age and older who have no
antiretroviral treatment history and HIV-1 RNA levels less than or equal
to 100,000 copies per mL. Odefsey is also indicated as replacement for a
stable antiretroviral regimen in those who are virologically-suppressed
(HIV-1 RNA less than 50 copies per mL) for at least six months with no
history of treatment failure and no known substitutions associated with
resistance to the individual components of Odefsey. No dosage adjustment
of Odefsey is required in patients with estimated creatinine clearance
greater than or equal to 30 mL per minute.
Odefsey has a boxed warning in its product label regarding the
risks of lactic acidosis/severe hepatomegaly with steatosis, and post
treatment acute exacerbation of hepatitis B. See below for important
Photos and multimedia gallery available at www.GileadHIVMedia.com.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high
antiviral efficacy similar to and at a dose less than one-tenth that of
Gilead’s Viread® (tenofovir disoproxil fumarate, TDF). TAF
has also demonstrated improvement in surrogate laboratory markers of
renal and bone safety as compared to TDF in clinical trials in
combination with other antiretroviral agents. Data show that because TAF
enters cells, including HIV-infected cells, more efficiently than TDF,
it can be given at a much lower dose and there is 90 percent less
tenofovir in the bloodstream.
“As people are living longer with HIV, there is an increasing need to
develop new treatments that are tolerable and help address long-term
health for patients,” said John C. Martin, PhD, Chairman and Chief
Executive Officer, Gilead Sciences. “Odefsey’s safety, efficacy and
tolerability profile offers a new treatment option to support the needs
of a range of patients and represents Gilead’s commitment to innovation
in the field of HIV.”
The approval is supported by a bioequivalence study demonstrating that
Odefsey achieved similar drug levels of emtricitabine and TAF in the
blood as Genvoya® (elvitegravir 150 mg/cobicistat 150
mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and
similar drug levels of rilpivirine as Edurant® (rilpivirine
25 mg). The safety, efficacy and tolerability of Odefsey is supported by
clinical studies of rilpivirine-based therapy (administered as R+F/TDF
or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a
range of patients with HIV, including treatment-naïve adults and
adolescents, virologically suppressed adults who switched from PI-,
NNRTI- and INSTI-based regimens and virologically suppressed adults with
mild-to-moderate renal impairment.
The Odefsey approval is part of an ongoing development and
commercialization agreement between Gilead and Janssen, first
established in 2009. Under this agreement, Gilead is responsible for the
manufacturing, registration, distribution and commercialization of the
product in most countries, while Janssen will distribute it in
approximately 17 markets and have co-detailing rights in several key
markets, including the United States. The original agreement was
established for the development and commercialization of Complera®,
marketed as Eviplera® in the European Union, and expanded in
2014 to include Odefsey.
Odefsey does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead’s U.S. Advancing Access® program provides assistance
to appropriate patients in the United States who are uninsured,
underinsured or who need financial assistance to pay for their
medications, including Odefsey.
The program offers information and assistance for patients, including:
Additionally, Gilead is working closely with the ADAP Crisis Task Force,
as the company has done for each of its other HIV medications, to
provide discounts to state AIDS Drug Assistance Programs (ADAPs) that
will help ensure access to Odefsey for patients who receive medications
through these programs.
Information about how to apply for any of these forms of assistance can
be found at www.GileadAdvancingAccess.com
or by calling 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. EST.
Important U.S. Safety Information for Odefsey
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
Warnings and precautions
Dosage and administration
Pregnancy and lactation
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 risk
that physicians may not see the benefits of prescribing Odefsey. 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, 2015, 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
U.S. Full Prescribing Information, including BOXED WARNING,
for Odefsey is available at www.gilead.com.
U.S. Full Prescribing Information, including BOXED WARNING,
for Genvoya, Stribild, Complera, Truvada and Viread are available at www.gilead.com.
Odefsey, Genvoya, Stribild, Complera, Truvada, Eviplera,
Viread and Advancing Access are registered trademarks of Gilead
Sciences, Inc., or its related companies.
Edurant is a registered trademark of Janssen Sciences Ireland UC.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160301006840/en/
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.Patrick O’Brien, 650-522-1936 (Investors)Ryan
McKeel, 650-377-3548 (Media)