Gardasil Anal Cancer Indication Passes FDA Muster; Next Stop Is ACIP
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
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Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
FDA rejects broader indication for the HPV vaccine and revises labeling to include information about a lack of demonstrated efficacy in women older than 26.
Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
FDA rejects broader indication for the HPV vaccine and revises labeling to include information about a lack of demonstrated efficacy in women older than 26.
Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
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.