logo
Plus   Neg
Share
Email
Comment

Gilead Sciences HIV Drug Quad Gets FDA Panel Backing

Gilead Sciences Inc. (GILD) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Asia-focused lender HSBC Holdings Plc reported late Monday a significant growth in fiscal 2017 profit, reflecting higher revenues and the absence of loss related to Brazil operations. The company noted that all of its global businesses grew adjusted profits and three main global businesses generated improved adjusted revenue. Further, the company maintained its dividend. Tech giants Amazon.com, YouTube and Twitter as well as Verizon Communications are exploring bids for digital streaming rights to the National Football League or NFL's Thursday Night Football package, according to media reports. The NFL is likely to strike a multi-year deal for the digital streaming rights. However, the television audience for the NFL has declined for two consecutive years. Wynn Resorts Ltd. said Friday that former Chief Executive Officer Steve Wynn is not entitled to any severance payment of other compensation from the company. Wynn resigned last week as CEO and Chairman of the board following allegations of sexual misconduct. In a regulatory filing, Wynn Resorts said it entered into a separation agreement between Steve Wynn, and Wynn Resorts Holdings LLC.
comments powered by Disqus
Follow RTT