Glaxo Wins Positive Opinion on Drug
GlaxoSmithKline said that its cervical cancer vaccine Cervarix received a positive opinion from the European Committee for Human Medicinal Products and will now be proposed for final approval by the European Commission.
The conclusion Wednesday on Cervarix, which is expected to become a multibillion-dollar product, came after the committee reviewed data from clinical trials in almost 30,000 females, including data from the largest Phase III cervical cancer vaccine efficacy trial to date.
Cervarix will now be submitted for Commission approval, and a marketing authorization could be granted in the coming months, the company said.
In the United States, Cervarix is under review by the Food and Drug Administration. If approved, it would enter the market against Merck's Gardasil. Glaxo has said it expects to get the drug to the U.S. market sometime in 2008. It has been approved by health regulators in Australia.
Glaxo shares gained 1.3% to 1,286 pence ($26.37) on the London Stock Exchange.