Merck & Co has failed in its bid to get approval to expand the use of its cervical cancer vaccine Gardasil to include older women.
The US Food and Drug Administration has completed its review of a supplemental biologics license application for an indication to use Gardasil in women aged 27-45. Approval has not been granted, Merck noted, and instead the label has been updated to state that the vaccine has not been demonstrated to prevent human papillomavirus-related cervical intraepithelial neoplasia (CIN) 2/3 or worse in women older than 26.
In the USA, Gardasil is approved for use in girls and young women 9-26 for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. It is also indicated for precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18, and approved for anal cancer in boys and men of that age group.
The FDA's rejection is a disappointment for Merck which saw sales of Gardasil fall 12% in 2010 to $988 million.