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Merck Closer to FDA Gardasil Approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

An FDA advisory committee voted 13 to 0 to endorse Merck vaccine, Gardasil, which blocks a sexually transmitted virus that causes cervical cancer. U.S. advisers unanimously said it was safe and effective for women and girls as young as 9 years old. The panel said it was persuaded by Merck’s data showing Gardasil prevented early-stage cervical cancer and precancerous lesions. Gardasil targets common types of the sexually transmitted human papilloma virus, or HPV, which causes genital and skin warts and most cervical cancer.

Gardasil is a key product for Merck. Some analysts predict annual sales topping $2 billion. A final FDA decision is expected soon, putting Merck ahead of a potential rival vaccine by GlaxoSmithKline. If approved in Europe, Merck and Sanofi-Aventis would market Gardasil through a joint venture. Merck licensed the vaccine technology from Australian company CSL Ltd.

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