GSK Receives FDA Approval For Cervarix

The FDA has approved GlaxoSmithKline’s (GSK) 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).

Reportedly, the approval 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 US in late 2009.

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 company has said that 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 the study, 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 has showed an overall efficacy of 70% 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% 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.

According to the company, 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 study results suggested that Cervarix has a clinically acceptable safety profile.

Deirdre Connelly, president of North American Pharmaceuticals at GSK, said: “The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women. Immunisation with a vaccine such as Cervarix , along with annual doctor visits and Pap tests, will help protect women from cervical cancer.”