FDA approves Gilead’s latest HIV treatment
pharmafile | April 5, 2016 | News story | Manufacturing and Production, Research and Development | Gilead, HIV, descovy, taf, taf-based, therapy
Gilead (NASDAQ: GILD) has announced that the US Food and Drug Administration has approved their TAF-based HIV therapy, Descovy (emtricitabine, tenofovir alafenamide) and indicated the treatment in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients aged 12 and over.
This treatment received a positive opinion from the EMA in February, which has now been followed by this approval from the FDA. Descovy is Gilead’s third TAF-based HIV therapy which is a form of treatment that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth of Gilead’s Viread.
This approval is supported by data from two Phase III clinical trials which met its primary endpoints of non-inferiority compared to F/TDF-based regimens, as well as equalling the drug levels of TAF and emtricitabine in the blood as Genvoya.
Norbert Bischofberger, chief scientific officer at Gilead, comments: “As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy patients a simple and effective combination with a safety profile that has the potential to improve health.
“With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide.”
Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Sean Murray
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