FDA approves Glaxo's cervical cancer vaccine

WASHINGTON -- GlaxoSmithKline said Friday U.S. regulators approved its vaccine Cervarix to prevent the leading cause of cervical cancer in women, following a two-year delay.

The approval from the Food and Drug Administration allows the British drug maker to compete against Merck's billion-dollar selling vaccine Gardasil, which has been on the U.S. market since 2006. Glaxo said it expects to launch Cervarix in the U.S. later this year.

Cervarix is already approved in nearly 100 other countries, but had been delayed in the U.S. since 2007. The FDA had requested more data on muscular and neurological problems, which turned out to be unrelated to the vaccine. Side effects from Cervarix were mostly mild, including pain and swelling at the injection site, fatigue and headache.

The vaccine blocks human papilloma virus strains 16 and 18, the two types of HPV that cause 75 percent of cervical cancers. Glaxo said the vaccine is also highly effective against strain 31, which is the third most common HPV type that causes cancer. There are more than 100 types of HPV, though about 15 are known to cause cervical cancer.

Cervarix's effectiveness against extra strains of the virus could help differentiate it from Gardasil, which protects against HPV 16 and 18, but not other cancerous strains.

SeparatelyMerck said the FDA cleared its Gardasil vaccine to prevent genital warts in boys ages 9 to 26. While the new use for the vaccine could double the market for Gardasil, analysts do not expect it to be widely used in boys because genital warts caused by HPV usually clear up by themselves.
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Still, Glaxo is likely to face an uphill battle in the U.S. Besides an established brand, Merck's vaccine also defends against two HPV types that cause 90 percent of genital warts, which Cervarix does not target.

Gardasil became an early success story for Merck after its 2006 launch, achieving sales that are rare for a vaccine. The Whitehouse Station, N.J., company has sold about 50 million doses worldwide, with more than $1.4 billion in revenue last year. But sales have been slowing amid questions about the longevity of the vaccine's effect and its price tag of nearly $400 for the three-injection regimen. Glaxo has not discussed pricing for its vaccine.

HPV infects about 6 million people in the U.S. each year, and is spread mainly through sexual contact. It usually causes no symptoms and goes away within two years, although rare cases can develop into warts and cancer in both men and women.

Last year, nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all deaths from cancer.