US FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine

Following a recent favorable recommendation from an advisory committee, on October 16 the US Food and Drug Administration gave final approval for UK drug giant GlaxoSmithKline's 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).

Cervarix, which will have to compete with the already well-established Gardasil from domestic major Merck & Co, is expected to be commercially available in the USA in late 2009. Gardasil generated revenues of $1.4 billion last year, but sales have been slowing, and Merck has just had its product cleared for use in genital warts in men and boys (see separate story today).

"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," she added.

Cervarix was 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. The majority (approximately 7% of cervical cancers in North America are caused by HPV types 16 and 18, the company notes.