Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women
This article was originally published in The Pink Sheet Daily
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.
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Japan Clears Merck's Gardasil To Ease HPV Vaccine Shortage; AstraZeneca, Astellas Also Gain Approvals
July kicks off a good start for the Japanese subsidiary of Merck & Co. Inc., known as Merck, Sharp & Dohme, with three new drug approvals from Japan's Ministry of Health, Labor and Welfare. Among them, cervical cancer vaccine Gardasil will largely benefit from a recently expanded Japanese government public coverage program for human papillomavirus vaccines
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.
Company unveils data at European conference supporting use in women ages 27 through 45; data was sent to FDA late last year.