Shire receives CHMP backing for paediatric Revestive approval

Shire has announced that its new short bowel syndrome therapy Revestive has been recommended for approval by European regulators in a new paediatric indication.

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the extension of the approval of Revestive to encompass paediatric patients aged one to 17 years.

Data from a recent clinical study has demonstrated the effectiveness of the drug in this patient group, with these findings underpinning the CHMP's verdict. A final ruling from the European Commission is now expected in August.

Dr Philip Vickers, head of research and development at Shire, said: "We await the final decision of the European Medicines Agency and the potential to bring a new treatment option for children and adolescents suffering from short bowel syndrome in Europe."

Short bowel syndrome is a rare gastrointestinal condition characterised by a clinically significant reduction in intestinal absorptive capacity as a consequence of surgical resection of large portions of the intestine.

Revestive is already available in Europe for the treatment of this condition in adult patients.