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FDA panel backs broader label for Gardasil

November 18, 2010 1:39 AM UTC

FDA's Vaccines and Related Biological Products Advisory Committee on Wednesday supported approval of Gardasil HPV vaccine from Merck & Co. Inc. (NYSE:MRK) to include the prevention of anal intraepithelial neoplasia (AIN) and anal cancer caused by HPV types 6, 11, 16 and 18 in males and females ages 9-26 years. The committee also said it is reasonable to extrapolate efficacy data in males to support the indication in females. Merck submitted a single Phase III trial conducted only in males as part of the sBLA. The company said it expects a decision by year end. The committee did not take any votes. ...