NEW YORK, Jan 13 (Reuters) - Merck & Co (MRK.N) on Wednesday said it had provided U.S. regulators with new information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 to 45.
Gardasil, one of Merck’s biggest products, was approved in 2006 for preventing cervical cancer and genital warts in females between the ages of 9 and 26. It works by preventing infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer.
The U.S. Food and Drug Administration early last year again withheld approval for its use by women aged 27 to 45, asking the drugmaker to submit data when a 48-month study on a test group has been completed.
Merck, in a statement on its Web site, said it had provided the completed trial data to the FDA before the end of 2009. The company said the FDA typically takes six months to review such responses.
Global sales of Gardasil fell 22 percent to $311 million in the third quarter, hurt by overseas competition from GlaxoSmithKline’s (GSK.L) rival Cervarix vaccine and continuing delays in winning expanded approval for the product. (Reporting by Ransdell Pierson; editing by Carol Bishopric)