HPV vaccines regulatory update

FDA's Vaccines and Related Biological Products Advisory Committee will meet Sept. 9 to discuss vaccines against HPV from GlaxoSmithKline and Merck. The panel will discuss the use in males of Merck's Gardasil, an HPV types 6, 11, 16 and 18 recombinant vaccine that is already approved for females ages 9-26. An sBLA for Gardasil is under review to prevent external genital lesions caused by HPV types 6, 11, 16 and 18 in males ages 9-26, with a decision expected this fall. Gardasil is marketed in the U.S. by Merck and in Europe by Sanofi Pasteur MSD, a JV between Merck and sanofi-aventis Group (Euronext:SAN; NYSE:SNY, Paris, France). ...