US FDA panel backs Glaxo cervical cancer vaccine

GlaxoSmithKline PLC’s proposed cervical cancer vaccine is safe and effective for girls and young women ages 10 to 25, a U.S. advisory panel said on Wednesday.

The endorsement from Food and Drug Administration advisers moves the Cervarix vaccine closer to the U.S. market to compete with Merck & Co’s Gardasil shot.

The panel will vote later Wednesday on whether Merck should be allowed to widen its potential market by promoting Gardasil for men and boys as young as 9 for prevention of genital warts.

Both vaccines are designed to protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

FDA advisers, in an 11-1 vote, said Cervarix appeared safe. Some urged monitoring of miscarriages, which were reported at a higher rate around the time of vaccination compared with a hepatitis A shot. Others urged tracking of muscle and neurological problems seen in a small number of patients.

“The data we have seen to date are reassuring, said Dr. LisaRider, a panel member and official at the National Institutes of Health, adding “I think we do need very strong post-marketing studies” of autoimmune conditions that could cause neurological harm.

The committee voted 12-1 that Cervarix was effective.

The FDA usually follows panel recommendations. Glaxo said a final decision on Cervarix may come as early as this month.

The vaccine already is approved in 98 countries, but some analysts say it will be hard for Glaxo to compete against Gardasil’s three-year headstart in the U.S. market. Gardasil won FDA clearance in 2006, while Cervarix stalled following Glaxo’s initial application in 2007.

Cervical cancer is often caught early in the United States through Pap smears while the disease is treatable. 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.

“If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year,” said Barbara Howe, director of Glaxo’s North American vaccine development.

The company promised to track potential complications and miscarriages after approval. Neither Cervarix nor Gardasil is recommended for pregnant women.

Both vaccines fight two HPV strains that cause about 70 percent of cervical cancers. Gardasil also targets two other HPV strains that cause genital warts. It is unclear how long protection lasts or if booster shots will be needed.

HPV also can cause penile and anal cancers in males, although both are rare.

By Lisa Richwine
GAITHERSBURG, Md.(Reuters)