GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in Japan, GlaxoSmithKline

Release Date: 2009-10-16

Landmark approval paves the way for access to the vaccine for women in Japan

GlaxoSmithKline (GSK) today gained 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). This approval marks a significant milestone for GSK, as Cervarix® will be the first vaccine to be launched by the company’s Japanese business. The vaccine, which is formulated with GSK’s innovative 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.
Cervical cancer currently kills an estimated 3,500 Japanese women each yearand research has shown that incidence of the disease is on the increase, particularly amongst women in their 20’s and 30’s where it is now the leading cause of cancer in the country.
Marc Dunoyer, President of GlaxoSmithKline 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.”
This landmark approval will be the 99th licence obtained to date around the world. These include the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan.
Jean Stephenne, President and General Manager of GSK Biologicals commented, “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.”
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. These data demonstrated that the vaccinewas highly effective at protecting against the twomost 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. In addition, a recently published study in the International Journal of Gynecological Cancer, supported these findings, demonstrating that vaccination with Cervarix® resulted in a strong immune response against HPV types 16 and 18 in Japanese women.
About Cervarix ®
Cervarix ® was specifically designed with a novel adjuvant, AS04, to deliver high and sustained levels of antibodies aimed at providing long-term protection against HPV 16 and 18, the most common cervical cancer-causing HPV types. It has been shown to be generally well tolerated. The most common symptoms after vaccination included pain, redness and swelling at the injection site, fatigue, fever, aching, headache, itching, rash or gastrointestinal disturbances.
To date, Cervarix ® has now been approved in 99 countries around the world, including Japan, the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries including the United States. GSK also submitted the vaccine to the World Health Organization (WHO) for prequalification in September 2007.

Type:	NORMAL
Company:	GlaxoSmithKline
Country:	United Kingdom