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Home Industry News GSK cervical cancer vaccine gets positive CHMP opinion

GSK cervical cancer vaccine gets positive CHMP opinion

19th July 2007

GlaxoSmithKline has announced that its cervical cancer candidate vaccine Cervarix has received a positive opinion from the Committee of Human Medicinal Products (CHMP) of the European Medicines Agency for the prevention of cervical cancer related to human papillomavirus types 16 and 18 and prevention of precancerous lesions.

This opinion was granted following the review of positive clinical trial data involving 30,000 patients, including the largest phase III trial of the efficacy of a cervical cancer vaccine to date.

Cervarix is formulated with AS04 – an innovative adjuvant system designed to boost the immune response and consequently the duration of protection against cancer-causing virus types offered by the vaccine.

Marketing authorisation for the vaccine will now be proposed and may be granted by the European Commission in the next few months.

J P Garnier, chief executive officer of GSK, said: “Today’s positive opinion from the CHMP is great news for women across Europe.

“It is a significant step towards achieving our ambition – to provide women with protection against cervical cancer.”

The company adds that, together with its recent publication of clinical trial results, this development marks the potential of Cervarix as a vaccine for the disease.

Last month, GSK announced the results of an interim analysis of a phase III clinical trial showing that Cervarix provides “excellent” protection against advanced precancerous lesions resulting from the most common types of human papillomavirus.

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