Pharmaceutical Business review

Health Canada Approves Merck’s Gardasil

In the Phase III clinical study conducted over three years with more than 4,000 males ages 16 to 26, the quadrivalent HPV vaccine was 89.4% efficacious in reducing the incidence of genital warts related to HPV types 6 and 11 among males who were naive to HPV types 6, 11, 16, and 18.

A separate Australian retrospective study to assess the impact of the national vaccination program with the quadrivalent HPV vaccine on females showed early benefits from vaccination. The study found a decline in genital warts cases in the targeted female population as well as a drop in genital warts among heterosexual but not homosexual men.

Dr Charles Lynde, a practising dermatologist and assistant clinical professor at University of Toronto, said: “We have many treatments for genital warts which are often not all that effective. With Health Canada’s approval of the use of Merck’s vaccine in males, now rather than treating them after the fact, the prevention of warts for both sexes is possible in this country.”