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
Amazon.com Inc. on Tuesday introduced the latest generation of its flagship Fire tablet - the Fire HD 10. The new tablet comes with a 10.1 inch widescreen, 1080p display, ten hours of battery life, and Alexa hands-free capabilities. The Fire HD 10 is available for pre-order beginning today with 32GB or 64GB of internal storage, and starting at $149.99. Rite Aid Corp. and Walgreens Boots Alliance Inc. have secured regulatory clearance for an amended and restated purchase agreement, under which Walgreens will buy 1,932 stores, three distribution centers and related inventory from Rite Aid for $4.375 billion in cash. Department store operator Kohl's Corp. said that it will offer free, convenient returns for Amazon.com Inc. customers in 82 of its stores across Los Angeles and Chicago, starting in October. Kohl's will pack and ship eligible Amazon return items for free to Amazon return centers, thus providing an additional service and convenience to Amazon customers within select Kohl's stores.
comments powered by Disqus
Follow RTT