Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA not only has declined to approve Merck's human papillomavirus vaccine Gardasil for use in women ages 27-45, it has added to labeling a statement that the vaccine was not shown effective in preventing more serious HPV-related precancerous cervical lesions or cancer in the pivotal study targeting this age group.
You may also be interested in...
Gardasil Anal Cancer Indication Passes FDA Muster; Next Stop Is ACIP
Expanded indication does not actually expand the target population for the HPV vaccine, but the data should bolster Merck's argument for a routine vaccination recommendation in males when it goes before CDC's Advisory Committee on Immunization Practices.
Merck Looks To Mid-June FDA Decision On Expanded Use Of Gardasil To Older Women
Company unveils data at European conference supporting use in women ages 27 through 45; data was sent to FDA late last year.
Gardasil Label Expansion To Women 27-45 Delayed Until 2010, At The Earliest
Merck receives a second “complete response” letter from FDA related to its sBLA to extend indications for the vaccine to older women.