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Home Industry News Sanofi receives CHMP recommendation for HPV vaccine

Sanofi receives CHMP recommendation for HPV vaccine

28th February 2014

Sanofi has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its HPV vaccine Gardasil.

A two-dose schedule of the treatment has been recommended for the use with boys and girls aged nine to 13 years old. 

The application for a European licence for the drug was supported by the results of a clinical trial in Canada, which demonstrated antibody levels one month after a two-dose schedule of Gardasil are non-inferior to those observed following a three-dose schedule in women aged 16 to 26.

While a CHMP recommendation is not always followed by European Commission marketing approval, it is considered to be a key indicator of the likelihood. 

Gardasil is the only quadrivalent HPV vaccine and helps to protect against cervical cancer, genital precancerous lesions and genital warts. 

It is currently licensed as a three-dose vaccination and around 144 million doses have been distributed globally, with 29 million of these occurring within western Europe. ADNFCR-8000103-ID-801699333-ADNFCR

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