Merck & Co has presented data on Gardasil which shows that the vaccine, which is approved for cervical cancer, is also effective in the prevention of human papillomavirus-related disease in young men.
Data from a Phase III trial in men aged 16 to 26,which was presented at the European Research Organisation on Genital Infection and Neoplasia meeting in Nice, France, showed that Gardasil prevented 90% of external genital lesions caused by human papillomavirus types 6, 11, 16 and 18. These are the only data evaluating efficacy of any HPV vaccine in preventing disease in males, Merck noted.
In the study, 4,065 males received three injections of either Gardasil or placebo over a six-month period. The results showed that after a mean duration of about 29 months, three cases of genital warts were observed in the Gardasil group, compared with 31 for placebo. The jab was also found to be 85.6% effective at reducing persistent HPV infection.
Merck said that is on track to submit a supplemental Biologics License Application for Gardasil to the US Food and Drug Administration by the end of the year. The vaccine is currently approved for use in females aged 9 to 26 to prevent cervical, vulvar and vaginal cancers caused by HPV strains 16 and 18, and genital warts caused by HPV types 6 and 11.
An approval for males would provide a huge boost to Gardasil sales which has fallen off recently after its extremely successful launch in 2006. Third-quarter revenues from the vaccine were down 4% to $401 million.
According to WebMD "No serious side effects were linked to Gardasil, though participants who got Gardasil reported "slightly more" injection site reactions than participants in the placebo group, according to the researchers, who included Joel Palefsky, MD, of the University of California at San Francisco."
Merck, the drug company that makes Gardasil, funded the study.
By Kevin Grogan of PharmaTimes.