GlaxoSmithKline Files For Biologics License For HPV Drug
GlaxoSmithKline said Thursday it has submitted a biologics license application for Cervarix, its cervical cancer candidate vaccine, to the U.S. Food and Drug Administration.
If licensed, the vaccine will be indicated for the prevention of cervical cancer and pre-cancerous lesions associated with the most common cancer-causing human papillomavirus types, the company said.
Cervarix would be the second vaccine approved in the U.S. to prevent cervical cancer, following the approval of Merck's Gardasil last year.
"Competition is now officially on the horizon for Merck's new and highly controversial vaccine called Gardasil," said CNBC's Mike Huckman on "Street Signs."
According to Huckman, analysts estimate the market for the vaccines is at least $1 billion.
After breast cancer, cervical cancer is the second most frequently occurring cancer in women between the ages of 20 to 39 years in the U.S. The American Cancer Society estimates that in 2007 more than 11,000 women will be diagnosed with cervical cancer and nearly 4,000 will die from the disease in the U.S. About 2 million are diagnosed with precancerious lesions each year.