Please login to the form below

Not currently logged in
Email:
Password:

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

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Windrose Consulting Group

Windrose Consulting Group helps life science companies maximize the commercial value of their products and bring new innovations to market...

Latest intelligence

digital healthcare chronic disease
Digital healthcare may revolutionise management of chronic diseases, but who is going to pay for it?
Providers are looking at digital solutions to transform this area of healthcare...
Live webinar:
The power of a good story: Turn your insights into effective storytelling with data visualisation...
clinical research org
The important role of CROs in shaping the future of clinical research across Europe
Looking at the impact of COVID-19 on clinical research activities...

Infographics