EU CHMP recommends approval of Revestive (teduglutide) for injection in paediatric patients (aged one to 17 years) with short bowel syndrome- Shire

Shire has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Revestive (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS).

Recommendation was based on a 12-week, open-label, multicentre, safety, pharmacokinetic and pharmacodynamic study which was conducted in 42 children aged 1-17 years who had SBS with Intestinal Failure for at least one year and had plateaued in PS reduction with minimal or no advance in enteral nutrition for at least three months. Of the 42 patients, 40 (95%) completed the study. Most adverse events were related to gastrointestinal complaints and/or central line-related issues. No deaths were reported, no serious drug-related adverse events were observed, and no patient discontinued the study due to adverse events. No safety signals related to fluid overload, obstruction, hepatobiliary system, or colonic polyps were seen in the study.

Comment: Revestive is currently indicated in Europe for the treatment of adult patients with SBS, who should be stable following a period of intestinal adaptation after surgery, in Canada for the treatment of adult patients with SBS who are dependent on parenteral support (PS), and in the United States under the name Gattex (teduglutide) for injection for the treatment of adult patients with SBS who are dependent on PS.