Gardasil reduces HPV disease burden in men

Results of a pivotal Phase III study show for the first time that Gardasil, a cervical cancer vaccine developed by US drug major Merck & Co and French pharmaceutical giant Sanofi-Aventis, may help reduce the burden of human papilloma virus-related diseases in men.

Presented at the European Research Organization on Genital Infection and Neoplasia annual meeting, held in Nice, France, the study of 4,000 males aged 16-26 found that the vaccine prevented 90% of external genital lesions related to HPV types 6, 11, 16 and 18. No vaccine-related serious adverse events were reported in the study.

Merck says it remains on track to submit a supplemental Biologics License Application for Gardasil for the treatment of males to the US Food and Drug Administration by the end of this year.