U.S. approves Glaxo's cervical cancer vaccine

WASHINGTON (Reuters) - GlaxoSmithKline PLC won U.S. approval on Friday to sell a long-delayed vaccine against the virus that causes cervical cancer.

The British company's Cervarix vaccine will compete with Merck & Co's blockbuster Gardasil shot. Both injections provide protection against human papillomavirus, or HPV, which causes cervical cancer and genital warts.

Some analysts say it will be hard to compete against Merck's three-year head start in the U.S. market. Gardasil won FDA clearance in 2006, while the launch of Cervarix was stalled after the Food and Drug Administration asked for more information following Glaxo's initial application in 2007.

The Merck vaccine had global sales of $1.4 billion in 2008, compared with more than $200 million for Cervarix.

In the United States, cervical cancer is often caught early, while the disease is treatable, through Pap smears. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.

Gardasil has generated controversy over potential side effects as well as the cost of about $360 for preventing a disease that is treatable if caught early.

The FDA and Centers for Disease Control and Prevention say Gardasil remains safe with no unusual complications, and problems such fainting and nausea remain rare.

Both Cervarix and Gardasil fight two HPV strains that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts.

(Reporting by Lisa Richwine; Editing by Lisa Von Ahn)