FDA approves Gilead’s Odefsey for treatment of HIV-1 infection
pharmafile | March 2, 2016 | News story | Research and Development, Sales and Marketing | Gilead Sciences, HIV, Odefsey
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved its TAF-based single tablet regimen Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) for the treatment of HIV-1 infection in certain patients.
This is Gilead’s second TAF-based regimen to receive FDA approval, and represents the smallest pill of any single tablet regimen for the treatment of HIV. The first, Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), received FDA approval in November 2015, and was followed by an EU endorsement in December.
Odefsey is a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. This drug is also indicated as a suitable replacement for a stable antiretroviral regimen in those who are virologically-supressed for at least six months with no history of treatment failure.
The efficacy of TAF in entering cells, including HIV-infected cells, and acting in a potent antiviral capacity is more efficient rate than TDF, with only one-tenth of the TAF dose required to achieve the same results as Gilead’s branded TDF regimen, Viread (tenofovir disoproxil fumarate).
It was demonstrated in a bioequivalence study that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya, whose own Phase III clinical trials were hailed a success last October.
John Martin, chairman and chief executive at Gilead, comments: “As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients. Odefsey’s safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead’s commitment to innovation in the field of HIV.
Following the announcement of positive TAF clinical trial results in recent times, Gilead will be hoping this second TAF-based regimen to receive FDA approval will go some way to reclaiming the market share that has been lost to ViiV Healthcare, which has diminished Gilead’s former dominance in the space with products such as Triumeq (dolutegravir, abacavir and 3TC).
Sean Murray
Related Content
Gilead Foundation awards $6.5m in grants to support STEM education
Gilead Sciences has committed over $6.5m in grant funding towards improving science, technology, engineering and …
European Commission approves HIV prevention injection
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first …
HIV vaccine candidate successfully optimised for industrial production
Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered …
