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GSK's Rotarix rotavirus vaccine wins FDA review

GSK wins FDA review for its Biologics License Application for Rotarix, an orally available candidate vaccine for infants to prevent rotavirus gastroenteritis

GlaxoSmithKline (GSK) has won FDA review for its Biologics License Application (BLA) for Rotarix, an orally available candidate vaccine for infants to prevent rotavirus gastroenteritis.

The BLA for the GSK rotavirus candidate vaccine is based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. The clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.

Rotavirus is the most common cause of hospitalisation due to severe dehydration caused by vomiting and diarrhoea in children worldwide according to the ESPID-ESPGHAN Rotavirus Expert Group.

Of children hospitalised with rotavirus, approximately 17 per cent are aged under six months old.  If approved, the GSK candidate vaccine would provide completion of the rotavirus vaccination series by four months. 

In the US, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination against rotavirus to prevent rotavirus gastroenteritis with the vaccine currently licensed by the FDA at two, four, and six months of age.

GSK's Rotarix vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain.

Rotarix was first launched in Mexico in 2005 and has already been licensed in a total of 33 countries. GSK Bio submitted a registration file for Rotarix to the European Medicines Agency (EMEA) in December 2004.

By 2010, the potential market for rotavirus vaccines is estimated to be between GBP 1bn to GBP 1.3bn worldwide.

15th August 2007

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