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Gilead files Complera follow-up with FDA

HIV therapy could be approved in the US by the end of this year

Gilead Sciences 

Gilead Sciences has filed a three-drug HIV therapy with an FDA priority review voucher that means it could be approved in the US before the end of the year. 

The triple therapy is a follow-up to Gilead's Complera - a triple therapy based on emtricitabine, Janssen's rilpivirine and tenofovir disoproxil fumarate - with the latter replaced with improved ingredient tenofovir alafenamide or TAF.

Complera - which has been on the market since 2011- has quickly become one of the most widely-prescribed HIV therapies in the US and is on course to become a blockbuster this year with sales of $320m in the first three months of the year, up 27% on the same period of 2014.

Gilead is in the process of advancing a number of new TAF-based HIV products that substitute for TDF which is effective but is prone to renal and bone side effects. TAF is more than 10 times more potent than its parent, so is associated with a more benign safety profile.

The new product - known as R/F/TAF - has been submitted for the treatment of HIV-1 infection in adult and paediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen, according to Gilead.

In addition to R/F/TAF, Gilead has also filed for approval of a combination of emtricitabine and TAF (F/TAF), which will be a direct replacement for its blockbuster HIV therapy Truvada that brought in $3.3bn for the company in 2014.

Meanwhile, a four-drug combination of TAF plus elvitegravir, emtricitabine and cobicistat (E/C/F/TAF) - a follow-up to TDF-based Stribild - is also under review by the FDA.

"R/F/TAF is Gilead's third TAF-based filing in less than a year, and we are looking forward to the potential to offer people living with HIV another effective treatment option with a favourable safety profile," said Norbert Bischofberger, the company's chief scientific officer.

"If all applications progress successfully to approval, we would be able to launch three new TAF containing HIV regimens between November 2015 and the middle of 2016."

The priority review voucher used for R/F/TAF was acquired from Canada's Knight Therapeutics in November last year. Knight secured the voucher after getting FDA approval for Impavido, a drug to treat leishmaniasis, with Gilead paying $125m for the transferrable rights.

Article by
Phil Taylor

2nd July 2015

From: Sales

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