The US Food and Drug Administration has approved Merck & Co’s Gardasil, which is used to prevent cervical cancer in women, for the prevention of genital warts in young men.

Specifically the agency has given the go-ahead for Gardasil to be used in boys and men aged 9-26 for the prevention of genital warts caused by human papillomavirus types 6 and 11. Richard Haupt, executive director at Merck Research Laboratories, said the approval is “an important milestone, because the use of Gardasil can now help protect boys and girls and young men and women from certain diseases caused by this common virus”.

Analysts believe that the approval for boys could add up to $300 million to sales of Gardasil which fell 18% to $268 million in the second quarter. However one of the problems Merck faces is getting the vaccine to be included in routine vaccination programmes.

Merck said that the FDA approval “is the first step in an important two-step process”, The next stage is an Advisory Committee on Immunisation Practices vote on whether to recommend administration of Gardasil for use in males, as well as public funding through the US Centers for Disease Control and Prevention (CDC) contract. These votes are expected on October 21.

However, an analysis carried out by researchers at the Harvard School of Public Health and published earlier this month in the British Medical Journal, suggested that including preadolescent boys into the programme is not cost-effective.