logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Advisory Panel Oks Gilead's Once-Daily Quad Single Tablet Regimen For HIV

Gilead Sciences Inc. (GILD) announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration or FDA has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

Gilead said it submitted the NDA on October 27, 2011 and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 27, 2012.

The company noted that applications for marketing approval of the Quad are also pending in Australia, Canada and the European Union.

The company stated that the Quad NDA is supported by the positive results from two pivotal Phase 3 studies in which Quad met its primary objective of non-inferiority as compared to Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (Study 103).

The NDA is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single tablet regimen.

In all studies, the Quad was well tolerated and most adverse events were mild to moderate. The most common adverse events observed were nausea, diarrhea, upper respiratory track infection and headache, the company said.

The company noted that the Quad contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg, a "boosting" agent that enables elvitegravir once-daily dosing; and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Internet access is growing worldwide, but there is still a long way to go before the entire world is completely wired, a study from the Pew Research Center has found. The study also noted that men have greater access to the Internet than women in many nations. Backtracking on its early announcements on digital privacy, WhatsApp is planning to share member information, phone numbers and analytical data with Facebook, to make revenue from the platform. Discount retailers Dollar Tree Inc. and Dollar General Corp. both reported results for the second quarter that missed analysts' expectations. Looking ahead, Dollar Tree also forecast revenue for the third quarter below analysts' estimates and lowered its full-year revenue outlook. Shares of both companies are falling in pre-market activity.
comments powered by Disqus
Follow RTT