Shire submits to extend label for Gattex, to include children

13 November 2018

Rare disease specialist Shire (LSE: SHP) has filed to extend the label for Gattex (teduglutide) in the USA to include pediatric patients with short bowel syndrome (SBS) who are dependent on parenteral support.

The therapy is currently approved for adult patients. The US Food and Drug Administration has set a target date for a decision on the supplemental application of March 2019.

SBS is a serious, chronic and rare malabsorption disorder resulting from surgical resection.

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