European approval for GSK’s cancer vaccine
pharmafile | September 25, 2007 | News story | Sales and Marketing |
GlaxoSmithKline's cervical cancer vaccine Cervarix has been approved in Europe, setting it up for a head-to-head clash with Sanofi-Pasteur MSD's rival treatment Gardasil.
Cervarix had been racing Gardasil to become the first cervical cancer vaccine to come to market until clinical delays forced it to cede the prize to its rival, which was approved last year in Europe and the US.
One key claim Cervarix has over its rival is that it is formulated with a new technology which enhances the immune response and increase the duration of protection against cancer-causing virus types.
Cervarix is indicated for the prevention of precancerous cervical lesions and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.
Although there are around 100 types of HPV, types 16 and 18 are responsible for more than 72% of all cervical cancers in Europe.
Despite screening for early detection, cervical cancer is the second most common cause of death from cancer (after breast cancer) among women aged 15-44 in Europe.
GSKs chief executive JP Garnier said: "The decision to approve Cervarix for the European Union represents a great step forward for European women. Physicians across Europe will now have access to this important vaccine to help protect women against cervical cancer, the second most common cancer in women."
To regain some of the ground it has already lost to its rival, GSK initiated a head-to-head trial of Cervarix and Gardasil in January this year.
Its main aim will be to compare the vaccine's immune responses to HPV types 16 and 18 in women aged 18 to 26, with secondary goals of assessing responses in those aged 27 to 35 and 36 to 45.
