Shire gets positive opinion from EMA on rare gastrointestinal disease treatment
pharmafile | May 27, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | CHMP, EMA, Revestive, Shire, gastrointestinal, paediatric, short bowel syndrome, treatment
Shire (LSE: SHP) has announced that it has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the extension of the approval for Revestive (tedglutide) in paediatric patients with short bowel syndrome.
Short bowel syndrome (SBS) is a rare gastrointestinal condition which is 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 drug is an analogue of human glucagon like peptide 2 (GLP-2) that enhances key structural and functional adaptations in the intestinal mucosa.
Revestive is currently approved in adult patients with SBS and this latest positive opinion will form the basis of an approval for the treatment in paediatric patients aged one to 17. A decision is expected from the European Commission to extend the marketing authorisation of the drug in August 2016.
Philip J. Vickers, head of R&D at Shire, says: “We are delighted that the CHMP has rendered a favourable recommendation for tedglutide in paediatric patients based on their evaluation of the data and benefit-to-risk balance. 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.”
Sean Murray
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