GlaxoSmithKline said that it has submitted a licence application for its cervical cancer candidate vaccine Cervarix to the Japanese Ministry of Health, Labor and Welfare (MHLW). This is the first vaccine for the prevention of cervical cancer to be filed for approval in Japan, said the company in a press release.
GSK's cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, intended to enhance immune response and increase duration of protection. The licence applied for is for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types.
The incidence of cervical cancer in Japan is on the increase. With 2,500 deaths and 7,000 new cases diagnosed per year, cervical cancer has become the most common cancer in Japanese women in their 20s and 30s and the second most common cancer in Japanese women overall, the company said.
"With rising rates of cervical cancer, especially in younger Japanese women, Japanis a priority country for GSK's cervical cancer candidate vaccine. This filing submission includes a vast amount of data on the efficacy and safety of the candidate vaccine in Asian women. The submission follows other recent approvals across the Asia-Pacific region, and launches in Australiaand the Philippines. We look forward to the opportunity of ensuring that Japanese women will equally have access to our vaccine, for protection against this life-threatening disease, said Jean Stephenne, president and general manager, GSK Biologicals.
The file submitted to the MHLW includes data from clinical trials in almost 30,000 females 10 to 55 years of age across four continents. The submission also included data from the largest phase III cervical cancer vaccine efficacy trial to date, which demonstrated that GSK's cervical cancer candidate vaccine was highly efficacious and was generally well tolerated.
Recent European marketing authorisation, granted on 21st September 2007, indicates GSK's cervical cancer candidate vaccine for the prevention of precancerous cervical lesions (high-grade cervical intraepithelial neoplasia [CIN] grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18. The indication is based on data generated in girls and women aged between 10 and 25, stated the press release.
GSK's cervical cancer candidate vaccine is formulated with a novel proprietary adjuvant system called AS04, which is designed to enhance the immune response and increase the duration of protection against cancer-causing virus types.
GSK's cervical cancer candidate vaccine is indicated in the EU for the prevention of high-grade cervical intraepithelial neoplasia (CINgrades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.5
In May 2007, the candidate vaccine was granted its first license in a major market by the Therapeutic Goods Administration (TGA) of Australia for the prevention of cervical cancer and precancerous lesions caused by human papillomavirus types 16 and 18 for use in females aged between 10 and 45 years. This is the first time that a cervical cancer vaccine has been approved with an explicit indication anywhere in the world for women over the age of 26. Subsequent licenses have been granted in other international markets, the press release said.
GSK submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its cervical cancer candidate vaccine in March 2007, following earlier regulatory filings with the European Medicines Agency (EMEA) and regulatory filings in Africa, Asia and Latin America.