Merck files Gardasil data for older women with FDA
This article was originally published in Scrip
Executive Summary
Merck has submitted long-term 48-month data from its Phase III FUTURE trial to the US FDA with hopes that it will convince the agency to approve its blockbuster cervical cancer vaccine Gardasil in older women, aged 27-45. The FDA has accepted the filing and the company is anticipating a decision within the next six months.