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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Gilead Sciences' fixed-dose HIV combination pill Odefsey featuring emtricitabine 200 mg, rilpivirine 25 mg, and tenofovir alafenamide (TAF) 25 mg.
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TAF is a novel targeted prodrug of tenofovir that has showed high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate; TDF).
Surrogate laboratory markers of renal and bone safety was also improved, compared to TDF in clinical trials in combination with other antiretroviral agents.
The CHMP recommended Odefsey to treat of adults and adolescents aged 12 years and older weighing at least 35 kg with HIV-1 infection without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, tenofovir, or emtricitabine and with a viral load of 100,000 or fewer HIV-1 RNA copies per mL.
The Odefsey CHMP opinion is part of a development and commercialization agreement between Gilead and Janssen signed in 2009.
Under the deal, and pending the product’s approval, Gilead will manufacture, register, distribute and commercialize the product in majority of countries.
Janssen will distribute it in about 17 markets and have co-detailing rights in various key markets, including the US.
The original agreement was signed to develop and commercialize Eviplera, marketed as Complera in the US, and was expanded in 2014 to include Odefsey.