A panel of experts have recommended that the FDA approve Gardasil for the prevention of anal cancer and anal intraepithelial neoplasia (AIN). Anal cancer is a relatively rare disease, affecting about 5,000 people in the U.S. each year. An overwhelming majority of anal cancer cases are thought to be the result of HPV infection. Merck's vaccines is already approved for the prevention of four strains of the HPV virus, cervical cancer and genital warts.
"We are pleased with the outcome of today's meeting and look forward to continued discussions with the FDA as it evaluates the data for the proposed indication," said Elizabeth Garner, director of clinical research at Merck Research Laboratories said in a statement. "Today's discussion brings us closer to being able to also provide GARDASIL to men and women for the prevention of anal cancer and AIN."
- check out Merck's release on the committee recommendation
- take a look at the Bloomberg article