GSK’s Application for Rotarix Accepted for FDA Review

GlaxoSmithKline (GSK) announced that the FDA has accepted for review its biologics license application (BLA) for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.

The BLA for Rotarix includes data from nearly 75,000 infants in the Americas, Europe, Asia and Africa, reflecting an ethnically diverse population, GSK said.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is among several organizations recommending that infants receive routine vaccination against rotavirus with the vaccine currently licensed by the FDA at two, four, and six months of age.