April 29, 2016
European CHMP Adopts Positive Opinion for Gilead’s TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for Treatment of HIV
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 CHMP’s recommendation will now be reviewed by the
The MAA 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 supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or Eviplera®; R/F/TDF) 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, non-nucleoside reverse-transcriptase inhibitor-based regimens, or integrase strand transfer inhibitor-based regimens, and virologically suppressed adults with mild-to-moderate renal impairment.
The Odefsey CHMP opinion is part of an ongoing development and
commercialization agreement between Gilead and Janssen, first
established in 2009. Under this agreement, and pending the product’s
approval, Gilead will be 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
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 Odefsey may not be approved by the
The European SmPCs for Eviplera®, Edurant®, Genvoya® and Viread® and are available from the EMA website at www.ema.europa.eu.
Odefsey, Genvoya, Viread, Complera and Eviplera are registered
Edurant® is a registered trademark of Janssen Sciences Ireland UC.
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20160429005537/en/
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945