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news.The FDA has approved Merck & Co's drug Rotateq for the prevention of rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children.
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The drug is the only treatment currently available in the US for the prevention of the disease. There has been a gap in the market for such a vaccine since a previously released vaccine made by Wyeth had to be withdrawn from the market in 1999 after it was linked with a life-threatening complication.
Rotateq targets the strains of rotavirus responsible for more than 90% of rotavirus disease in the US. Among children under five in the US, it is estimated that 2.7 million episodes of rotavirus gastroenteritis occur each year, leading to approximately 250,000 emergency room visits and up to 70,000 hospitalizations.
“Virtually all children will experience rotavirus. While some children experience mild symptoms of rotavirus, infection can be severe and lead to dehydration that can be fatal,” said Dr Paul Offit, chief of infectious diseases at The Children’s Hospital of Philadelphia and co-inventor of the vaccine.
The FDA approval of Rotateq is based on data from the company’s phase III clinical trials of more than 70,000 infants.