GlaxoSmithKline gained approval for Cervarix in Japan, becoming the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).

The vaccine, which is formulated with GSK’s AS04 adjuvant system, has been licensed for the prevention of pre-cancerous lesions (cervical intraepithelial neoplasia – CIN 2 and 3) and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by human papillomavirus (HPV) types 16 and 18, in girls and women aged 10 and above.

The approval was based on data supporting the efficacy and safety profile of the vaccine, which included analysis of the largest efficacy trial of a cervical cancer vaccine, involving nearly 19,000 women. These data demonstrated that the vaccine was highly effective at protecting against the two most common cervical cancer-causing HPV types, 16 and 18. The study also showed that rates of serious adverse events and medically significant conditions in the group vaccinated with Cervarix were similar to the control group.

Marc Dunoyer, president of GSK Japan, commented, “We are extremely pleased with the approval of Cervarix, which is designed to protect women from cervical cancer – a disease that is responsible for the death of 10 Japanese women every day. Experts believe that vaccination in conjunction with regular screening will significantly reduce the burden of cervical cancer, and GSK is committed to working alongside the Japanese government to help ensure that women and girls are educated about the role that vaccination can play in protecting them against it.”

The vaccine is currently approved in the 27 member states of the EU, Australia, Brazil, South Korea, Mexico and Taiwan.