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FDA panel backs Glaxo cancer vaccine

Merck’s Gardasil also gets support

By Matthew Perrone
Associated Press / September 10, 2009

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WASHINGTON - Drug maker Merck is likely to face US competition for its vaccine Gardasil, after federal experts recommended rival GlaxoSmithKline’s Cervarix also be approved to prevent the virus that causes most cervical cancers.

The FDA’s panel of vaccine experts voted overwhelmingly yesterday that Cervarix appears safe and effective for girls and women ages 10 to 25.

If the FDA follows the group’s advice as it usually does, Glaxo would begin competing against Merck’s Gardasil, which has controlled the US market since 2006.

But Merck won its own small victory at the meeting, as the same panel recommended Gardasil be expanded to prevent genital warts in boys, a new use for a vaccine that already posts sales of more than $1 billion.

While panelists favored the expanded approval, they questioned how widely the vaccine would be used, since genital warts are not a serious medical condition.

“Genital warts are a nuisance, they’re ugly and can sometimes be stigmatizing,’’ said Dr. Kenneth Noller of Tufts University. “But in men and women with healthy immune systems they go away by themselves.’’

The human papilloma virus, or HPV, infects about 6 million people in the United States each year, and is mainly spread through sexual contact.

It usually causes no symptoms and goes away within two years, though rare cases can develop into warts and cancer in men and women.

Last year nearly 4,000 women died of cervical cancer in the United States, less than 1 percent of all cancer related deaths.

London-based drug maker Glaxo already has won approval for Cervarix in Europe, but its US launch was delayed in 2007 when the FDA said it needed more data.

Panelists said newer studies suggest the vaccine is safe, but they recommended follow-up studies to monitor miscarriages and inflammatory-muscular problems reported by a small number of patients.

The group said it was unlikely those problems were related to the vaccine, but said the issues should still appear on product labeling. “I think this could be marketed with the usual caveat that it’s not to be used during pregnancy,’’ Noller said.

Even if the FDA grants approval, Glaxo will face an uphill battle against competitor Merck. Besides an established brand in the United States, Gardasil also boasts an extra degree of protection against sexually transmitted diseases.

Gardasil and Cervarix both defend against HPV strains 16 and 18, which cause about 70 percent of cervical cancer cases. But Merck’s vaccine also defends against two other HPV types that cause 90 percent of genital warts, something Cervarix does not target.