FDA posts Gardasil briefing documents

FDA said in briefing documents posted ahead of the Vaccines and Related Biological Products Advisory Committee meeting on Nov. 17 that data support approval of Gardasil HPV vaccine from Merck & Co. Inc. (NYSE:MRK) to prevent anal intraepithelial neoplasia (AIN) and anal cancer caused by HPV types 6, 11, 16 and 18 in males and females ages 9-26 years. An sBLA for the indication is under FDA review.

FDA's Center for Biologics Evaluation and Research (CBER) also concluded that 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 application. ...