FDA approves GSK's Rotarix

GlaxoSmithKline has won FDA approval for Rotarix, an oral vaccine for the prevention of rotavirus in infants and children. Though rarely fatal, rotavirus sends approximately 55,000 children to the hospital each year. Rotarix will compete with Merck's RotaTeq, which has been on the market since 2006. And GSK's drug enjoys one advantage over Merck's: it can be given in two doses rather than the three RotaTeq requires.

Last year the FDA warned doctors and parents that RotaTeq may have caused intussusception--a potentially deadly twisting of the bowels--in 28 children. Wyeth's RotaShield vaccine was withdrawn from the market in 1999 when it was associated with the same problem. However, the FDA said the 28 cases were on par with what is expected to occur naturally each year. GSK's Rotarix packaging does not mention the possibility of intussusception, but that could change once it's on the market.

- see GSK's release
- read this Associated Press report for more

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