
Shire gets extended market authorization in Europe for drug to treat children with a rare gastrointestinal condition
pharmafile | July 7, 2016 | News story | Research and Development, Sales and Marketing | European Commission, Revestive, Shire, market authorisation, short bowel syndrome
UK drugmaker Shire (LSE: SHP) said the European Commission has granted extension of Market Authorization for Revestive (teduglutide) to treat short bowel syndrome (SBS) in children.
Ueli Fankhauser, head, global product strategy, said: “We are very pleased to be able to bring Revestive, the first product indicated specifically to treat paediatric SBS patients in Europe. This extension of EU Market Authorization for Revestive represents an important advance in the treatment of SBS in paediatric patients.”
Patients should be stable following a period of intestinal adaptation after surgery, the company said in a statement.
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.
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.
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.
Anjali Shukla
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