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Home Industry News GlaxoSmithKline applies for EU approval of new Cervarix regimen

GlaxoSmithKline applies for EU approval of new Cervarix regimen

9th August 2013

GlaxoSmithKline has applied to the European Medicines Agency (EMA) for approval of a new two-dose schedule for its cervical cancer vaccine Cervarix.

The marketing authorisation application would allow for administration according to a two-dose schedule in girls aged nine to 14 years old for the prevention of premalignant genital lesions and cervical cancer causally related to certain oncogenic human papillomavirus types.

Currently, the vaccine is specified for use in a three-dosing regimen, with the new indication intended as an alternative to the current schedule, rather than a replacement.

GlaxoSmithKline is yet to receive regulatory approval for the use of this new Cervarix regimen anywhere in the world.

This comes after the firm announced earlier this week that it is also applying to the EMA for approval of its oncology agent Votrient as a maintenance treatment for patients with stage II to IV ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first-line chemotherapy.ADNFCR-8000103-ID-801623022-ADNFCR

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