Gilead Sciences has submitted a new drug application for the marketing approval of its once-daily HIV treatment elvitegravir in the US.
The company, which has a strong focus in developing HIV medicines, is asking the Food and Drug Administration (FDA) to approve the drug's use in treatment of HIV-1 infection in treatment-experienced adults.
It follows a similar submission to the European Medicines Agency (EMA) in May, 2012, for European approval.
Elvitegravir is an integrase inhibitor that treats people with HIV by hindering the ability of the virus to integrate into the genetic material of human cells.
Gilead licensed the drug from Japan Tobacco in March 2005 and has exclusive rights to develop and commercialise elvitegravir in all regions, excluding Japan, where Japan Tobacco retains rights.
In clinical trials, the drug has demonstrated it was as effective as Merck's Isentress (raltegravir) – a fellow integrase inhibitor.
However, patients may prefer Gilead's product due to its once-daily regimen compared with Isentress' twice-daily method.
In addition to its use as a single pill, elvitegravir is part of Gilead's Quad pill that also aims to boost adherence in people with HIV through its once-daily single tablet regimen.
The combined pill also includes cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) and has received backing from an FDA panel in the treatment of HIV-1 infection in treatment-naïve adults. A final decision on Quad is expected by August, 2012.
Meanwhile, Truvada is still under review by the FDA, with a final approval decision expected soon. If passed by the regulator Truvada it would be the first drug approved in the US to reduce the risk of HIV-1 infection among uninfected adults, rather than to just treat the infection.