Shire plc recently announced that the Committee for Medicine Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion of Revestive (teduglutide) to treat pediatric short bowl syndrome patients.
With this positive opinion, CHMP recommends that Revestive receive extended approval. This five-milligram solvent and powder is an injection that can benefit pediatric medicine. Patients from the ages of one to 17 can use this medicine to treat their short bowel syndrome.
“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,” Philip Vickers, head of research and development for Shire, said. “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.”
Teduglutide, an analogue of human glucagon, is similar to peptide 2, also called GLP-2. This important analogue improves the important functions and structures of the body’s intestinal mucosa.
Now that CHMP has given a positive opinion and recommendation, the European Commission (EC) will review the opinion. EC health leaders will then choose whether to broaden the marketing approval for the new treatment throughout the European Union by August 2016.
