Glaxo finally wins FDA approval for Cervarix

After a delay of two years and approvals in nearly 100 other countries, the FDA finally gave GlaxoSmithKline a green light to start selling the HPV vaccine Cervarix on Friday. And Glaxo says that it will start marketing the cervical cancer vaccine in the U.S. before the end of the year.

Cervarix has demonstrated a high level of success in combating the three most common strains of HPV. Strains 16 and 18 trigger about 75 percent of all cervical cancers, though there are about 15 that can cause the disease. Cervarix's ability to block strain 31, the third most common type of the virus that causes cancer, could give it a distinct edge against the blockbuster Gardasil, which is sold by Merck.

The focus on Cervarix will now switch from approval to marketing success. Merck has had a three-year run at the U.S. market without any competition. But its sales have slowed as controversy continues to dog the vaccine and parents question the $400 cost. Merck, meanwhile, got an approval to sell Gardasil for the prevention of male genital warts.

- here's the Dow Jones report
- here's the story from the AP

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