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LONDON, May 27 (Reuters) - The world's first life-savinggene therapy for children, developed by GlaxoSmithKline and Italian scientists, was approved for sale in Europe onFriday, in a step forward for the pioneering technology to fixfaulty genes.
Called Strimvelis, it is designed for a tiny number ofchildren with ADA Severe Combined Immune Deficiency (ADA-SCID).SCID is sometimes known as "bubble baby" disease, since thoseborn with it have immune systems so weak they must live ingerm-free environments.
Strimvelis is the second gene therapy to be approved inEurope, after UniQure's Glybera, which treats a rareadult blood disorder.
Glybera made history in 2014 as the first drug to carry a $1million price tag. GSK has not so far revealed how much itsproduct will cost but a source close to the company said lastmonth it would be "very significantly less than $1 million".
The EU approval for GSK's treatment had been expected,following a positive opinion from the European Medicines Agencylast month.
The U.S. Food and Drug Administration has yet to approve anygene therapies but a growing number of U.S. biotech companieshave products in development. (Reporting by Ben Hirschler; editing by Adrian Croft)
