Shire's EU marketing authorization for Revestive extended to children with short bowel syndrome

7 July 2016

Ireland-headquartered Shire (LSE:SHP) has had its marketing authorization extended for its short bowel syndrome (SBS) treatment Revestive (teduglutide) by the European Commission to allow for use by pediatric patients.

The decision is based on the positive opinion on Revestive adopted by the Committee for Medicinal Products for Human Use of the European Medicines Agency in May and supportive pediatric data.

SBS is a rare gastrointestinal condition characterized by a clinically-significant reduction in intestinal absorptive capacity as a consequence of surgical resection of large portions of the intestine, commonly due to congenital abnormalities, disease or trauma.

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