Shire receives extension of Market Authorization in Europe for Revestive

First therapy indicated in the EU for use in patients aged one year and above with Short Bowel Syndrome, a rare gastrointestinal condition.

“We are very pleased to be able to bring Revestive, the first product indicated specifically to treat paediatric SBS patients in Europe,” said Ueli Fankhauser, Head, Global Product Strategy. “This extension of EU Market Authorization for Revestive represents an important advance in the treatment of SBS in paediatric patients.”

SBS is a rare gastrointestinal condition characterised 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.

The European Commission decision to grant extension of Market Authorization for Revestive in the treatment of paediatric patients with SBS follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in May 2016.

Estimates of the prevalence of SBS with Intestinal Failure (SBS-IF) in children vary markedly, largely due to the lack of standardised reporting and rarity of the disease. In a recent cross-sectional study in the Netherlands (the nationwide DRIFT registry study), the prevalence of chronic IF requiring home parenteral support (PS) was 9.6 per million in children. In the DRIFT registry population, 43.2% of children with chronic IF had SBS, which translates into a Dutch national prevalence of paediatric SBS-IF requiring home parenteral nutrition of 4.1 per million.