Breaking News
FONT-SIZE Plus   Neg
Share SHARE

Gilead Sciences HIV Drug Quad Gets FDA Panel Backing

RELATED NEWS
Trade GILD now with 

Gilead Sciences Inc. (GILD: Quote) Friday said that its experimental drug for treating HIV, known as Quad, won the backing of an FDA advisory panel.

The Antiviral Drugs Advisory Committee voted 13 to 1 in favor of Quad to treat HIV-1 infection in treatment-naive adults. The drug, which is a four-in-one combination pill of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, is meant to be taken once daily.

While the FDA is not bound by the recommendations of the panel, its guidance is usually considered by the agency. The FDA will take a final decision on the drug by August 27, 2012. Applications for marketing approval of Quad are also pending in Australia, Canada and the European Union. Market experts believe that the drug has potential to become a blockbuster.

"The Quad is the latest example of Gilead's ongoing efforts to develop highly effective and well tolerated single tablet regimens for people living with HIV," said Andrew Cheng, Senior Vice President, HIV Therapeutics and Development Operations, Gilead Sciences.

Quad's new drug application is supported by clinical studies, which met the primary study goals of being non-inferior as compared to other HIV drugs. The Quad was well tolerated with the most common adverse events noted being nausea, diarrhea, upper respiratory track infection and headache.

Currently, Gilead's Atripla is the most-prescribed HIV treatment regimen in the US. For the first quarter of 2012, Atripla sales increased 19 percent to $887.6 million, while sales from Truvada, another HIV drug, increased 13 percent to $758.3 million.

GILD closed Friday's trading on the Nasdaq at $51.84, up $0.59 or 1.15%, on a volume of 9.6 million shares.

Register
To receive FREE breaking news email alerts for Gilead Sciences Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
The Bank of Japan expanded its massive quantitative and qualitative easing unexpectedly as policymakers assessed it necessary to achieve the 2 percent inflation target even after a sales tax hike in April. In a 5-4 vote, the Policy Board led by Governor Haruhiko Kuroda decided to raise the monetary base at an annual pace of about JPY 80 trillion. LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its third quarter loss widened slightly from last year, as higher costs and expenses more than offset a 45% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. After ending the previous session modestly lower, stocks moved mostly higher over the course of the trading day on Thursday. The gains on the day more than offset yesterday's losses, lifting the major averages to their best closing levels in a month.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.