GSK announces EU Cervarix approval

GlaxoSmithKline (GSK) has announced that its vaccine Cervarix has received marketing approval for use in the European Union for the prevention of cervical cancer related to human papillomavirus (HPV) types 16 and 18 and precancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3).

This approval is based on a range of clinical trial data, with phase III studies showing the compound to provide 100 per cent protection against precancerous lesions causally related the HPV types 16 and 18 with this protection sustained for 5.5 years following vaccination.

Cervarix is manufactured using an innovative proprietary AS04 adjuvant system that seeks to boost the immune response and duration of protection offered by the vaccine.

J P Garnier, chief executive officer of GSK, said: “Physicians across Europe will now have access to this important vaccine to help protect women against cervical cancer, the second most common cancer in women.”

He added that this approval marks significant progress for women in Europe.

In June 2007, GSK reported that Cervarix provides women with “excellent” protection against the development of advanced precancerous lesions that are caused by the most common HPV types, with these results confirming those seen in earlier studies of the vaccine.