descovy

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

Related Content

China’s NMPA approves ViiV Healthcare’s Vocabria in combination with Rekambys for HIV treatment

ViiV Healthcare has announced that the National Medical Products Administration (NMPA) of China has approved …

Vaccine image

ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention

GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines …

FDA relaxes blood donation regulations for MSM

The US Food and Drug Administration (FDA) has released updated guidance for blood donation which …

Latest content