NEW YORK Jan 13 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
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)