Posted in ‘thepharmaletter.com’
19 November 2010
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has advised that the data presented support an indication for drug giant Merck & Co’s (NYSE: MRK) Gardasil ([Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant) for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females aged nine through 26 years.
“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, clinical research, at Merck Research Laboratories, adding that the “discussion brings us closer to being able to also provide Gardasil to men and women for the prevention of anal cancer and AIN.”
Anal cancer relatively rare in USA
Gardasil, Merck’s top-selling vaccine generated sales of $316 million in the third quarter of this year, an increase of 2% on the like 2009 period. However, anal cancer is relatively rare, affecting about 5,000 people in the USA each year, so the added indications is not likely to have a significant effect on revenues.