August 20, 2015
European Medicines Agency Validates Gilead’s Marketing Application for Single Tablet Regimen Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide (R/F/TAF) for HIV Treatment
– Gilead’s Third TAF-based Filing Under Review by EMA –
The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older.
“With this validation, R/F/TAF is now the third TAF-based filing under
review by the EMA as we advance a portfolio of new treatment options
that may offer high efficacy and favorable safety profiles,” said
TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials in combination with other antiretroviral agents.
In addition to R/F/TAF, two other MAAs for TAF-based regimens are under
review by the EMA. The MAA for an investigational, once-daily single
tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg,
emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF) was
fully validated on
The current MAA is supported by a bioequivalence study demonstrating that administration of R/F/TAF results in the same blood levels of emtricitabine and TAF as those that are achieved with E/C/F/TAF (10 mg TAF dosage) and the same levels of rilpivirine as a 25 mg dose of rilpivirine (Edurant®) alone. The safety and efficacy of TAF is supported by a number of clinical studies in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. In studies, TAF-based treatment (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to TDF-based therapy (administered as E/C/F/TDF or Stribild®).
The R/F/TAF filing will be reviewed by the EMA under the centralized
procedure, which, when finalized, may lead to the granting of marketing
authorization by the
The R/F/TAF filing is the latest step in an expanded 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 regimen in most
countries, while Janssen will distribute it in approximately 17 markets
and have co-detailing rights in several key markets. The original
agreement was established for the development and commercialization of
Eviplera®, marketed as Complera® in
A fourth investigational TAF-based regimen containing Gilead’s TAF, emtricitabine and cobicistat, and Janssen’s darunavir (D/C/F/TAF) is also under development under a separate licensing agreement. Under the agreement, Gilead is transferring to Janssen further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.
TAF and TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
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
possibility that the EMA may not adopt a positive opinion in its
evaluation and the
The European SmPCs for Stribild, Eviplera, and Viread are available from the EMA website at www.ema.europa.eu.
Edurant is a registered trademark of
Stribild, Complera, Eviplera and Viread are registered trademarks of
For more information on
View source version on businesswire.com: http://www.businesswire.com/news/home/20150820006134/en/
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Ryan McKeel, +1 650-377-3548
Kristine Kelly, +44 (0)78 1086 8956