RESEARCH TRIANGLE PARK, N.C. – GlaxoSmithKline is seeking approval from the U.S. Food and Drug Administration for a vaccine that targets viruses linked to cervical cancer.
GSK said Thursday that it had filed a former application with the FDA for Cervarix.
According to the American Cancer Society, some 11,000 women in the U.S. will be diagnosed with cervical cancer this year, and nearly 4,000 will die from it.
Cervarix is designed to prevent cervical cancer and precancerous lesions associated with the most common viruses linked to cervical cancer.
"Today’s filing is an important milestone for GSK and reflects our commitment to help prevent cervical cancer, the second most common cancer among younger women," said J.P. Garnier, chief executive officer of GSK. "We believe that the best possible protection against cervical cancer will include routine screening together with a vaccine designed to provide targeted, durable protection against the most common cancer-causing virus types."
In an interview with CCNMoney.com, Garnier said Cervarix is “the ultimate insurance for cervical cancer.” GSK hopes to receive FDA approval this year.
Gardisil, another cervical cancer vaccine, is already available from Merck.
GSK has submitted data demonstrating the efficacy of the vaccine gathered through clinical trials involving nearly 30,000 females between the ages of 10 and 55.