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Gardasil licence extension gets priority FDA review

Published on 28/03/08 at 11:42am

Merck has received priority review status from the FDA for its application to extend the licence of its cervical cancer vaccine Gardasil to include women aged 27 to 45.

Gardasil was approved in the US in 2006 for girls and women from nine to 26 years old for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by Human Papillomavirus (HPV) types 6, 11, 16 and 18.

The FDA's priority designation is only given for products or indications that address unmet medical needs, and the regulator is committed to reviewing and acting on 90% of biologics license application designated a priority within six months.

This means that if Merck is success in its application it will have won a further advantage in its fierce competition with GlaxoSmithKline's rival treatment Cervarix.

GSK's cervical cancer vaccine received European approval last October but is being held up by the FDA's demands for further clinical data and may be delayed until 2010.

This gives Gardasil a larger window of opportunity to establish itself in the all-important US market, where GSK's clinical delays have already allowed Merck a head start.

In response, GSK initiated a head-to-head trial of Cervarix and Gardasil in January this year. Although its main aim is to compare the vaccines' immune responses to HPV types 16 and 18 in women aged 18 to 26, its secondary goal is to assess responses in those aged 27 to 45 - the same age range as in Merck's new supplementary biologics licence application.

Gardasil and Cervarix are also at loggerheads in the UK market, where a decision is pending on which will be chosen for the NHS immunisation programme. GSK has recently re-organised PR support for its vaccine, choosing Clew Communications to handle the UK consumer and medical press accounts.

On its launch in the UK Gardasil caused a media furore, with critics questioning the morality of vaccinating girls as young as nine for protection against a virus acquired through sexual activity. But women remain at risk for newly-acquired HPV infections and developing HPV-related diseases throughout their lifetime.

Although there are around 100 types of HPV, types 16 and 18 are responsible for around 70% of all cervical cancers - the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 280,000 deaths each year.

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