FDA Panel Backs Glaxo's Cervical Vaccine for Women

Drugmaker Merck likely will face U.S. 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 Wednesday 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 U.S. 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 U.S. 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 both men and women.

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

London-based drugmaker Glaxo already has won approval for Cervarix in Europe, but its U.S. 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.