In a setback to Merck, the FDA has refused to approve the use of the Gardasil vaccine for preventing HPV in women ages 27 to 45, a market the drugmaker has been counting on to boost sorely needed vaccine revenue. In a brief statement, Merck says prescribing info was updated to indicate Gardasil has not demonstrated to prevent HPV-related cervical cancer in women older than 26.
The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story).
The vaccine is already approved to protect against the 6, 11, 16 and 18 strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts, anal cancer, anal dysplasias and precancerous lesions in males of the same age. Nonetheless, Gardasil sales have slowed considerably, from $1.4 billion in 2008 to $988 million last year (see page 6 of this SEC filing).