logo
Share SHARE
FONT-SIZE Plus   Neg

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
Lab equipment maker Thermo Fisher Scientific Inc. has agreed to acquire electron microscope maker FEI Co. for about $4.2 billion in cash, the two companies said Friday. Thermo Fisher noted that FEI's electron microscopy platform will complement its own mass spectrometry systems to accelerate advancements in structural biology. While reporting a wider loss for the first quarter, Sears Holdings Corp. said it has decided to "aggressively evaluate" all potential alternatives for its top brands - Kenmore, Craftsman and DieHard or KCD, and the Sears Home Services or SHS businesses. Sears has retained Citigroup Global Markets and LionTree Advisors to assist in its efforts. Philips Lighting, the splinter group of Dutch consumer electronics giant Philips, saw its shares rally around 8.50 percent on its debut on Friday at the Amsterdam stock exchange. The shares are currently at 21.70 euros, above its set pricing of 20 euros per share.
comments powered by Disqus
Follow RTT