British drugmaker GlaxoSmithKline (GSK) has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its cervical cancer vaccine, Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant].

New Drug Approvals

The application in the EU is to allow administration of the vaccine in a two dosing schedule (0, 6 months) in 9-14 year old girls.

Intended to serve as an alternative dosing schedule, the two-dose schedule will help prevent premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types. It does not seek to replace the three-dose schedule.

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http://regulatoryaffairs.pharmaceutical-business-review.com/news/gsk-submits-cervarix-two-dose-schedule-application-in-eu-080813

Cervarix is a vaccine against certain types of cancer-causing human papillomavirus (HPV).

Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix also contains AS04, a proprietary adjuvant that has been found to boost the immune system response for a longer period…

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