Gilead, Janssen Advance HIV Combo Drug
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Gilead Sciences, Inc.’s company's marketing authorization application (MAA) for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg (R/F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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.

TAF is an investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated 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 December 23, 2014. The MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) was fully validated on May 28, 2015. Gilead has submitted new drug applications to the US Food and Drug Administration for E/C/F/TAF, F/TAF, and R/F/TAF on November 5, 2014, April 7, 2015, and July 1, 2015, respectively.

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 European Commission, which is valid in all 28 member states of the European Union.

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, and 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 the United States.

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.

Source: Gilead Sciences

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