Shire receives new paediatric approval for Revestive

Shire has announced that its drug Revestive has been approved in a new paediatric indication in Europe.

The therapy, which consists of a five mg teduglutide powder and solvent solution for injection, has had its marketing authorisation expanded to include the treatment of patients aged one year and above with short bowel syndrome (SBS).

A 12-week study was conducted in 42 children that demonstrated the safety and effectiveness of this treatment among patients aged between one and 17. Results from this trial were used to support this new approval.

Revestive has been approved for use in the treatment of adult patients with SBS since 2012.

Ueli Fankhauser, head of global product strategy at Shire, said: "This extension of EU market authorisation for Revestive represents an important advance in the treatment of SBS in paediatric patients."

The company recently announced new clinical data from a trial of its drug SHP465-306, showing its effectiveness in treating attention deficit hyperactivity disorder in adults.