GlaxoSmithKline receives FDA approval for cervical cancer vaccine

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

"The approval of CERVARIX will bring an important new cervical cancer vaccine to girls and young women," said Deirdre Connelly, President, North American Pharmaceuticals, GlaxoSmithKline. "Immunization with a vaccine such as CERVARIX -- along with annual doctor visits and Pap tests -- will help protect women from cervical cancer, the second leading cause of cancer death in women in their twenties and thirties."

CERVARIX was shown to be 93 percent efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination. The majority (approximately 75 percent) of cervical cancers in North America are caused by HPV types 16 and 18.

The impact of CERVARIX against the overall burden of HPV-related cervical disease results from a combination of efficacy against, and disease contribution of, HPV-16, HPV-18, and oncogenic HPV types not included in the vaccine. In a subgroup of clinical trial participants without oncogenic HPV infection at the time of the first vaccination and without evidence of prior exposure to HPV 16 and 18, the vaccine showed an overall efficacy of 70 percent against pre-cancerous lesions, regardless of HPV type. In an additional analysis that assessed the impact of CERVARIX against specific HPV types not included in the vaccine, in women without oncogenic HPV infection with a specific type at the time of vaccination, approximately 89 percent efficacy was observed in the prevention of precancerous lesions associated with HPV type 31, the third most common cancer-causing virus type in North America.

CERVARIX does not protect against disease caused by all HPV types. Approximately 100 types of HPV have been identified to date and, of these, approximately 15 virus types are known to cause cervical cancer.

"The FDA approval of a vaccine, such as CERVARIX, is an important development in the prevention of cervical cancer," said Levi Downs, M.D., M.S., F.A.C.O.G., assistant professor in the Department of Obstetrics, Gynecology and Women's Health, University of Minnesota, a clinical trial investigator and consultant for GSK. "The treatment of cervical pre-cancers and cancer can be devastating for women and their families. It's important for a vaccine to help reduce the need for the invasive procedures often used to treat cervical pre-cancers and cancers."

CERVARIX has a clinically acceptable safety profile. The most common local adverse reactions and general adverse events in > or = 20 percent of clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, joint and muscle aching, and gastrointestinal symptoms.

The FDA's approval of CERVARIX was based on data from clinical trials in more than 30 countries involving a diverse population of nearly 30,000 girls and young women receiving CERVARIX.

CERVARIX is expected to be commercially available in the U.S. in late 2009.