June 23, 2016
European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV
– Odefsey is the Second Single Tablet Regimen Containing the
Descovy Backbone and the Third Product in Gilead’s New TAF
Portfolio to be Approved in
Odefsey is indicated in the
“People living with HIV today are increasingly likely to be receiving
treatment for other conditions – such as heart and liver disease –
because they are living longer than ever before, exposing them for
longer periods of time to the virus and to the medications used to treat
it. Therefore, we need new treatment options that are not only
efficacious but also tolerable, and with convenient dosing,” said
Photos and multimedia gallery available at www.GileadHIVEU.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.
“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,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “Through our new portfolio of products based on the Descovy backbone, Gilead is pleased to offer effective treatments and simple dosing options for people living with HIV, which has now become a chronic condition for most patients.”
The marketing authorization for Odefsey 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; E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey are also supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or Eviplera®; emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 245 mg)and F/TAF-based therapy (administered as Genvoya) in a range of patients with HIV-1 infection. These patients include treatment-naïve adults and adolescents, virologically suppressed adults who switched from protease inhibitor-based regimens, NNRTI-based regimens, or integrase strand transfer inhibitor-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment. As with all rilpivirine-containing regimens, Odefsey should be taken with food.
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
Odefsey in most countries, while Janssen will distribute it in
approximately 18 markets and have co-detailing rights in several key
For important safety information for Odefsey including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Odefsey available from the EMA website at www.ema.europa.eu.
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
The European SmPCs for Descovy, Edurant, Eviplera, Genvoya, Odefsey and Viread and are available from the EMA website at www.ema.europa.eu.
Descovy, Eviplera, Genvoya, Odefsey and Viread are registered
Complera and Edurant are registered trademarks of Janssen Sciences Ireland UC.
For more information on
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945