Gilead wins US FDA nod for TAF-based HIV drug
10 Nov 2015
The US Food and Drug Administration (FDA) has granted approval to the first tenofoviralafenamide (TAF)-based HIV drug, Genvoya, by pharmaceutical giant Gilead Sciences (GILD).
The TAF-based single-tablet regimen comprises TAF, Vitekta (elvitegravir), Tybost (cobicistat) and Emtriva. The drug has been verified to be effective against HIV-1 infection in adults and paediatric patients above 12 years with no antiretroviral treatment history.
The drug has been marked with warning regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute aggravation of hepatitis B.
Gilead has two other TAF-based regimens that still need consent from the US regulator. The company has also submitted a new drug application (NDA) to the FDA for a once-daily single-tablet regimen including its Emtriva and TAF and Johnson & Johnson's (JNJ) Edurant (rilpivirine).
Both the drugs have been presented for approval for treatment of HIV-1 infection in adults and paediatric patients above 12 years. Last year, the agency sanctioned two drugs by Gilead, Tybost and Vitekta, for treating HIV.
Despite attaining success in making drugs for treating HIV, Gilead's HCV drugs are facing hindrance with Sovaldi sales dropping 47.6 per cent from a year ago in the third quarter of 2015.