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 GlaxoSmithKline PLC said in a statement Thursday the approval would help speed access to Cervarix globally.
More than 80 percent of the estimated 280,000 cervical cancer deaths a year occur in developing countries. In the West, early diagnosis and treatment has slashed the disease's incidence.
Last year, the global health association GAVI, formerly known as the Global Alliance for Vaccines and Immunization, prioritized the purchase of cervical cancer vaccines for the world's 73 poorest countries. GAVI includes U.N. agencies, the World Bank and the Bill & Melinda Gates foundation and is a major buyer of vaccines for the developing world.
"Cervarix can save millions of women's lives throughout the world, but only if it reaches those who need it most," said Jean Stephenne, President of GSK Biologicals.
Cervarix has not been approved for use in the U.S. or Japan, but is available in 97 other countries. In the U.S., the cervical cancer vaccine market has been cornered by Gardasil since it was approved in 2006. Gardasil is made by Merck & Co. The vaccines typically cost about $360 for a three-shot dose.
The FDA is expected to decide within the next few months whether to approve Cervarix. Gardasil racked up $426 million in global sales in the most recent quarter, versus $69 million for Cervarix, which has won more contracts from government health programs beyond the United States.
It was unclear whether GSK might make Cervarix available at a cheaper price to U.N. agencies buying it for poor countries.
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