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FDA demands more Cervarix data

The FDA requests further information on GSK's cervical cancer vaccine, Cervarix, before it will grant marketing approval

UK-based pharmaceutical company GlaxoSmithKline (GSK) has revealed that the FDA has requested further information on its cervical cancer vaccine, Cervarix, before it will grant marketing approval.

GSK applied for US marketing approval of Cervarix in March 2007 and had expected a final response in early 2008. The vaccine could be a potential blockbuster for the company, which has seen drastically reduced sales of its second best-selling drug, the diabetes treatment Avandia (roseglitazone), due to cardiac safety concerns.

The company has also received a ìcomplete response letterî, which is issued when the review of a marketing application file is completed and questions remain to be answered prior to approval. It did not revealed what kind of information the FDA has requested.

Dr Barbara Howe, vice-president and director of GSK's North American Vaccine Development unit, said: "We have already started addressing the questions and will be engaged in discussions with the FDA to finalise our responses. Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring Cervarix to the US market."

GSK's shares dropped 0.8 per cent (GBP 0.11) to rest at GBP 13.12 on 17 December as a result. Cervarix could now experience a significant delay in reaching the US market, while Merck & Co and sanofi-aventis' own cervical cancer vaccine Gardasil, is already being used in widespread vaccination programmes in the region.

Gardasil targets four types of HPV, including two that cause genital warts, while Cervarix works against two forms of the virus, which cause the majority of cervical cancers. Cervarix's advantage over Gardasil is that it contains an adjuvant that enhances the body's immune response and increases the duration of protection.

17th December 2007

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