ARTICLE | Clinical News

Gardasil regulatory update

November 22, 2010 8:00 AM UTC

FDA's Vaccines and Related Biological Products Advisory Committee supported approval of Merck's Gardasil HPV vaccine 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. ...