GSK Receives Approval For Cervarix In Japan

Published: 16-Oct-2009

Paves the way for access to the vaccine for women in Japan for the prevention of pre-cancerous lesions and cervical cancer

GlaxoSmithKline (GSK) has received approval for Cervarix in Japan, which becomes the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW).

Reportedly, 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 caused by human papillomavirus (HPV) types 16 and 18, in girls and women aged 10 and above.

Included in the submission for this critical licence decision were key data supporting the efficacy and safety profile of the vaccine. This included the interim analysis of the largest efficacy trial of a cervical cancer vaccine, which involved nearly 19,000 women, a third of which were from Asia.

The result suggested that the vaccine was highly effective at protecting against the two most common cervical cancer-causing HPV types, 16 and 18. GSK has added that, a recently published study in the International Journal of Gynecological Cancer has supported these findings, demonstrating that vaccination with Cervarix resulted in a strong immune response against HPV types 16 and 18 in Japanese women.

Marc Dunoyer, president of GSK in Japan, said: “We are extremely pleased with the approval of Cervarix, which is designed to protect women from cervical cancer. 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.”

Jean Stephenne, president and general manager of GSK Biologicals, said: “We are delighted by today’s licensing approval in Japan, which will allow Japanese women and girls to join millions of others around the world in being able to benefit from the protection offered by this vaccine. This is particularly significant considering the increasing rates of incidence of this disease in Japan. This approval marks a significant milestone for GSK and further reinforces our confidence in the vaccine and the AS04 adjuvant system.”

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