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
Alphabet Inc., (GOOG, GOOGL), the parent company of Google, Thursday reported an increase in profit for the second quarter, driven mostly by increase in search and advertising revenues. Earnings and revenues for the quarter trumped Wall Street expectations, sending shares of the company up by 3 percent... Apple Inc. (AAPL) has announced that it recently sold its 1 billionth iPhone, about nine years after the first iPhone was launched. "iPhone has become one of the most important, world-changing and successful products in history. It's become more than a constant companion. iPhone is truly an essential... Fiat Chrysler Automobiles's US will focus on Jeep SUVs and Ram Pickups and plans to stop producing small passenger cars from early next year. The plan to stop Dart and Chrysler 200 production will be effective by first quarter of 2017. The new plans are expected to increase profit margins, as SUVs...
comments powered by Disqus
Follow RTT