Tokyo: GlaxoSmithKline won support for its cervical cancer vaccine from an advisory panel to Japan’s Health Ministry on Tuesday, putting it on track to be the first to offer such a vaccine in the world’s second-biggest drug market.
The ministry should give its final stamp of approval within a month, said Takehiro Kimura, a health ministry official.
On Monday, British health officials said a teenage girl died after receiving a cervical cancer vaccine made by Glaxo, though no link could be made between the death and the drug until all facts were known and a post-mortem conducted.
Approval in Japan could help clear the way for Merck & Co, which has also applied for approval for its Gardasil vaccine. Both Glaxo’s Cervarix and Merck’s Gardasil vaccines protect against infection from the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.
About 2,500 women die each year in Japan from cervical cancer. Worldwide deaths from the disease total about 280,000, mostly in developing countries with inadequate screening.
Glaxo’s Cervarix has already been approved in 98 countries, with sales in January-June nearly matching its annual sales of £125 million ($199 million) last year.
A US panel has also backed the vaccine for approval and a final decision could come this month, though Cervarix’s launch in the world’s largest drug market will lag Gardasil, which won approval three years ago.
Merck’s Gardasil vaccine has been approved for use in 112 countries, and logged $1.4 billion in sales in 2008.