Gilead uses voucher to speed FDA review of bictegravir

1 October 2017. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 10 August 2017, Gilead announced that the FDA of the bictegravir fixed-dose combination (FDC) would be processed using a priority review voucher.

These vouchers are bought and sold by companies and enable a faster review process.

In this case, the decision on the single tablet combination of the new integrase inhibitor, coformulated with tenofovir alafenamide (TAF) and emtricitabine (FTC) will be made by 12 February 2018.

The application was filed in the US in June 2017 and is also filed with the EMA in Europe.

Reference

Gilead press statement. Gilead announces U.S. FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV. (10 August 2017).
http://www.gilead.com/news/press-releases