FDA Approves Glaxo’s (NYSE: GSK) Cervical Cancer Vaccine Print E-mail
Friday, 16 October 2009 09:56

On 10/16/09, GlaxoSmithKline (NYSE: GSK) announced that the FDA 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).  Glaxo expects to launch CERVARIX in the U.S. before year-end.

CERVARIX has been shown to be 93% 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 (approximately 75% of cervical cancers in North America are caused by HPV types 16 and 18).

On 7/9/09, GSK announced that the World Health Organization (WHO) has approved its cervical cancer vaccine, Cervarix, which allows U.N. agencies to purchase the vaccine for poor countries worldwide. Cervarix represents the second cervical cancer vaccine approved by the WHO, adding to Merck's (NYSE: MRK) Gardasil.

On 3/30/09, GSK submitted final data from its Phase 3 pivotal efficacy study, HPV-008, to the FDA. HPV-008 is a Phase 3 clinical study of more than 18,600 women between 15-25 years of age, from 14 countries across Europe, Asia-Pacific and the Americas. The BLA for the vaccine includes safety, efficacy and immune response data from clinical trials in nearly 30,000 females and reflects an ethnically diverse population. To date, GSK's vaccine has been approved in more than 90 countries around the world including the 27 member countries of the European Union, Mexico, Australia, Singapore and the Philippines.

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