Merck fails to get approval to market Gardasil to women older than 27 for protection against HPV virus
Published: Wednesday, April 06, 2011, 7:00 PM Updated: Wednesday, April 06, 2011, 7:07 PM
By Bloomberg News
The Associated Press
Merck failed in its effort to win regulatory approval to market Gardasil as a protection against the HPV virus and cervical cancer to women between the ages of 27 and 45.
Federal drug regulators failed to grant Merck approval to expand the use of its cervical-cancer vaccine Gardasil to older women, the company said in a statement posted on its website.
Merck, which is based in Whitehouse Station, had sought approval from the Food and Drug Administration to market the vaccine to women between the ages of 27 and 45.
Gardasil is sold as a prevention against human papillomavirus infections, which can cause cervical cancer and genital warts. The vaccine won FDA approval in 2006 for use in female patients ages 9 to 26, and was cleared for males in that age group in 2009.
The vaccine generated $988 million in sales in 2010, a decrease of 12 percent from 2009, according to company filings.
In 2008, federal regulators granted a six-month expedited review of Merckís application to expand Gardasilís use to older women. The agency delayed its decision three times as it sought more information from the company.