Saturday, September 23, 2006

EU Approves Gardasil

PARIS (AFP) - Sanofi Pasteur MSD says it has won approval to begin selling Gardasil, the first vaccine against cervical cancer, in Europe.

The vaccine protects against the human papillomavirus (HPV), which causes genital warts that can lead to cancer. HPV infections are responsible for 70 percent of cervical cancer cases.

Sanofi Pasteur MSD, a joint venture between Sanofi-Aventis' vaccine unit and US pharmaceutical firm Merck, said it had been given the green light by the European Medicines Agency, the European equivalent of the US Food and Drug Administration.

Gardasil has already received approval in the United States, Mexico, Australia, Canada, New Zealand, Brazil.

Cervical cancer is the second most common cause of death from cancer, after breast cancer, among young women of 15-44 years in Europe, according to Sanofi Pasteur.

Approximately 33,500 women are diagnosed with, and 15,000 women die from, cervical cancer in Europe each year.

It is estimated that 250,000 new cases of genital warts in women related to human papillomavirus are diagnosed per year in Europe, according to the group.

Gardasil is indicated for the prevention of cervical carcinoma, high grade cervical dysplasia, high grade vulvar dysplastic lesions and external genital warts, and for the immunisation of children and adolescents of 9-15 years and adult females of 16-26 years of age.

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