by Ann Samuel on  August 15, 2007 at 2:13 PM Drug News
GlaxoSmithKline's Rotarix to  Be Reviewed
British pharmaceutical group GlaxoSmithKline announced Tuesday that US regulators have agreed to review Rotarix, a vaccine for children to prevent a deadly diarrhoea-inducing bug.

The review process by the US Food and Drug Administration (FDA) is the last hurdle before a possible green light to market the product in the United States.

"GlaxoSmithKline today announced that the US FDA has accepted for review its Biologics License Application for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis," GSK said in a statement.

Rotavirus is a diarrhoea-inducing bug that kills an estimated half a million children a year worldwide.

"This vaccine ... could make a considerable contribution in protecting very young infants from rotavirus disease, a significant burden on families and the healthcare system in the U.S.," added Barbara Howe, vice president of North American Vaccine Development at GlaxoSmithKline.

"We also believe it is important to immunize infants against rotavirus as early as possible."

The Rotarix vaccine has already been licensed in 99 countries around the world, including in the European Union.

Source: AFP

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