shire_image_4

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

Related Content

CHMP recommends Novo Nordisk’s Awiqli for diabetes treatment

Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for …

EC approves Pfizer’s Prevenar 20 to protect paediatric patients against pneumococcal disease

Pfizer has announced that the European Commission (EC) has granted marketing authorisation for Prevenar 20, …

louis-reed-pwckf7l4-no-unsplash_5

EMA validates two applications for datopotamab deruxtecan for cancer treatments

AstraZeneca has announced that the European Medicines Agency (EMA) has validated to marketing authorisation applications …

Latest content