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October 16, 2009

GSK Obtains FDA Nod for HPV Vaccine

  • FDA has approved GlaxoSmithKline’s (GSK) HPV vaccine Cervarix. It is indicated for the prevention of cervical precancers and cervical cancer associated with HPV types 16 and 18 for use in girls and young women between the ages of 10 and 25.

    Cervarix was shown to be 93% efficacious in the prevention of cervical precancers associated with HPV 16 or 18 in women without evidence of current infection with or prior exposure to the same HPV type at the time of vaccination.

    The FDA's sanction of Cervarix was based on data from clinical trials in more than 30 countries involving a diverse population of nearly 30,000 girls and young women receiving the vaccine.

    To date Cervarix has been approved in 100 countries around the world, including the 27 member states of the EU, Australia, Brazil, South Korea, Mexico, and Taiwan. It is administered in a three-dose schedule that should be completed within six months of the initial dose.


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