ZUG, Switzerland – May 27, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today 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). Teduglutide is an analogue of human glucagon like peptide 2 (GLP-2) that enhances key structural and functional adaptations in the intestinal mucosa.i
The European Commission (EC) will now consider the CHMP positive opinion in its final decision of whether to extend marketing authorisation for teduglutide in paediatric patients with SBS in the European Union; a final decision from the EC is expected in August 2016.
“We are delighted that the CHMP has rendered a favorable recommendation for teduglutide in paediatric patients based on their evaluation of the data and benefit-to-risk balance,” said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. “We await the final decision of the EMA and the potential to bring a new treatment option for children and adolescents suffering from SBS in Europe.”
Read more: https://www.shire.com/newsroom/2016/may/shire-receives-positive-chmp-opinion