Merck’s Gardasil Hits Snag

January 13, 2009

Merck’s Gardasil Hits Snag

Merck & Co. hit another setback in its effort to widen the use of the Gardasil cervical-cancer vaccine to older women as regulators requested more data on the proposed expansion.

The Whitehouse Station, N.J., drug maker said Friday the Food and Drug Administration wants to wait for the completion of a continuing trial of the vaccine in women 27 through 45 years old before deciding whether to approve its use by older women.

Merck said it expects to submit the results by year end, which means approval won’t come before 2010. Gardasil is currently approved to prevent cervical, vulvar and vaginal cancers, as well as genital warts, in females aged 9 to 26.

The latest delay further clouds the outlook for Gardasil, whose sales growth hit a wall last year after brisk growth following its introduction in 2006.

Wall Street
11th January 2009

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