FDAnews Drug Daily Bulletin

Following the European Commission’s approval of GlaxoSmithKline’s (GSK) cervical cancer vaccine Cervarix last month, the company submitted a file to the World Health Organization (WHO) to have the product prequalified for distribution in developing nations, the company announced recently.

The WHO prequalification program is intended to provide developing nations access to medicines that have been approved by recognized national health authorities. United Nations agencies and mass-vaccination programs can provide the products to poor countries once they are prequalified.

Cervarix (human papillomavirus vaccine [HPV], AS04 adjuvant-adsorbed) was approved in Europe for the prevention of high-grade cervical intraepithelial neoplasia causally related to HPV types 16 and 18.

The product has been launched and is priced in the UK the same as Merck’s Gardasil (quadrivalent HPV types 6, 11, 16, 18 recombinant vaccine). Sanofi-aventis’ vaccine division, sanofi pasteur, markets Gardasil in Europe.