EU adopts positive opinion for decision on regulatory approval of Quad
1 April 2013. Related: Antiretrovirals.
On 22 March 2013, Gilead announced in a press release that the EU has adopted a positive opinion for the once-daily, single tablet regimen Stribild (previously developed as Quad).
This indication is for use in treatment-naive and treatment-experienced patients.
Quad contains elvitegravir, an integrase inhibitor, and cobicistat, a PK booster, with tenofovir and FTC and was approved in the US in August 2012.
The decision came from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) and such recommendations are usually followed. Full approval is therefore expected within three months.
Gilead PR. European CHMP adopts positive opinion for Stribild, a once-daily, integrase inhibitor-based, single tablet regimen for the treatment of HIV-1 infection. (22 March 2013).