May 23, 2006
FDA advisory committee recommends Gardasil approval
The FDA's Vaccines and Related Biological Products Advisory Committee has unanimously recommended the approval of Merck’s experimental cervical cancer vaccine Gardasil.
The panel voted 13-0 that Gardasil was safe and effective in female patients as young as 13 years old.
The recommendation, although non-binding, is considered a positive for Merck, as the FDA usually follows the advice of its advisory committees.
The agency will make its final decision on Gardasil June 8. If approved, Gardasil could reach the market as early as this summer.
Analysts have predicted sales of Gardasil could reach the $1.5 billion mark—a figure that could help a beleaguered Merck offset some of the losses it incurred following the withdrawal of its $2.5 billion painkiller Vioxx.