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EMEA backs extended uses for Gardasil

The Committee for Medicinal Products for Human Use has given its backing for Sanofi Pasteur's application to extend the indications for its drug, Gardasil
The Committee for Medicinal Products for Human Use (CHMP) has given its backing for Sanofi Pasteur's application to extend the indications for its drug, Gardasil.

The European Medicines Agency (EMEA) has informed Sanofi Pasteur that the CHMP has recommended that the vaccine be used for the prevention of precancerous vaginal lesions caused by human papillomavirus (HPV) types 16 and 18.

Gardasil has been developed to prevent four different types of cervical cancer and is approved for use in 101 countries, with the drug having already been launched in 76 of them. It is currently approved in the EU for the inoculation of females aged between 9 and 26 for HPV types 6,11,16 and 18.

Elamr Joura, professor of gynaeco-oncology at the University of Vienna explained that precancerous vaginal lesions can be difficult to detect and are prone to recurrence.

"The treatment to avoid progression to cancer is challenging and often requires ablative therapy, partial vaginectomy and radiotherapy in the case of invasive cancer," Joura said.

"Women may suffer from anxiety, depression, sexual dysfunction and poor self-image, resulting in broken lives."

Sanofi Pasteur says that a decision on the extended marketing authorisation by the European Commission is expected within weeks.

Patrick Poirot, vice-president for medical and scientific affairs at Sanofi Pasteur, said: "This extension validates our comprehensive approach in addressing HPV-related genital diseases and our robust clinical development."

In March 2008, Sanofi Pasteur announced that results from clinical studies showed that Gardasil held an efficacy rate of 96 per cent. The Data and Safety Monitoring Board (DSMB) was prompted to recommend that the studies be stopped so women in the placebo group could be vaccinated with the drug.

3rd June 2008

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