FDA backs Gardasil for young men

Merck & Co.

As the US Food and Drug Administration finally makes moves to approve GSK's cervical cancer vaccine Cervarix, some good news for Merck & Co's Gardasil - Cervarix's key rival - also hits the headlines.

London-based pharmaceutical giant GSK had been waiting around for FDA approval of Cervarix for some time. The drug, which made headlines in the UK last month after a schoolgirl died just hours after receiving the vaccination, had been put on delay after the FDA failed to complete its review of the Biologics License Application for the drug.

Now though, after the FDA insisted there was no reason to assume the delay had anything to do with the death of the UK schoolgirl, and post mortem tests revealed the girl had died from a previously undetected chest tumour, approval has finally been received.

The move now places Cervarix on the US market against well-established rival jab Gardasil, produced by Merck & Co.

Approval

You'd be forgiven for thinking that the move would come as a blow to Merck & Co's drug, which has been on the market since 2006 - but Gardasil, in fact, received a boost of its own after the FDA also approved the drug for the prevention of genital warts in young men.

According to reports, 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 1.

The approval is being earmarked as "an important milestone" by Merck Research Laboratories executive director Richard Haupt, 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.

However, the FDA approval only marks the first step in an important two-step process.

Reports show 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. Votes are expected on 21 October.

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