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Gardasil delay in older women

Executive Summary

Merck's human papillomavirus vaccine Gardasil is unlikely to be approved in women 27 to 45 before 2010. The company received a second "complete response" letter from FDA in response to its sBLA seeking to extend the vaccine's indications to include older women, the firm says Jan. 9. FDA wants additional data from an ongoing clinical trial, FUTURE III, studying Gardasil in that patient population. Merck plans to submit the data to FDA in the fourth quarter when the 48-month trial is finished. Initial filing was based on 24 months of data from the trial. Expanding Gardasil's use to older women has proved challenging because the vaccine is thought to work best in women who have not been exposed to HPV, which is transmitted sexually. Even if Gardasil does receive FDA clearance in older women, the company could face resistance from managed care organizations due to questions about cost effectiveness

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