– ODEFSEY is the Second Single Tablet Regimen Containing the Descovy™ Backbone and the Third Product in Gilead's New TAF Portfolio to Receive Approval in Canada –
MISSISSAUGA, ON, Feb. 16, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for ODEFSEY™ (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) tablets as a complete regimen for the treatment of adults with HIV-1 infection. ODEFSEY is the most recent product approved from Gilead Canada's range of tenofovir alafenamide (TAF)-based regimens that include GENVOYA® and DESCOVY™.
ODEFSEY is indicated in Canada as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and who have HIV-1 RNA levels less than or equal to 100,000 copies per mL.
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 loads cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose resulting in >90 per cent lower concentrations of tenofovir in plasma.
"People living with HIV today are increasingly likely to be receiving treatment for other conditions, such as heart, kidney and liver disease, because they are living longer than ever before, exposing them for longer periods of time to the virus and to the antiviral medications used to treat it," said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta. "Therefore, we need new treatments that are not only efficacious, but well tolerated and simple to dose.
"In clinical studies, TAF has shown improvements in multiple bone and renal laboratory parameters compared to TDF (tenofovir disoproxil fumarate)," added Dr. Shafran. "ODEFSEY offers a new treatment option to support patients who are new to antiretroviral treatment, or who may be needing a replacement for an older antiretroviral regimen in those who are virologically suppressed. Today, the goal of treatment is beyond achieving an undetectable status, as we are now able to address longer-term side effects to help patients live an improved quality of life."
"The approval of ODEFSEY underscores Gilead's ongoing commitment to researching and developing new treatment options to help address the evolving needs of a range of HIV patients, which for many patients has now become a chronic condition," said Kennet Brysting, General Manager, Gilead Canada. "As such, novel simple and well tolerated treatments, such as TAF-based regimens, are becoming the cornerstone of HIV therapy."
ODEFSEY does not cure, nor prevent, HIV infection or AIDS.
Important Safety Information
The ODEFSEY Product Monograph has serious warnings regarding the risks of lactic acidosis, severe hepatomegaly with steatosis, and post treatment exacerbation of hepatitis B. For important safety information for ODEFSEY, including contraindications and additional warnings and precautions, please see the Canadian Product Monograph.
About Gilead Sciences
Gilead Sciences, Inc. (Gilead) 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. Gilead Sciences Canada, Inc., is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2005.
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 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.
Canadian Product Monograph for ODEFSEY™ is available at www.gilead.ca
COMPLERA®, DESCOVY™, GENVOYA®, ODEFSEY™ are 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
SOURCE Gilead Sciences, Inc.
For further information: FOR MORE INFORMATION IN CANADA, CONTACT: Karen M. Chow, National Stakeholder Relations and Communications, Gilead Sciences Canada, Inc., (905) 363-8083