Takeda granted EU approval for SBS therapy Revestive

Takeda and its partner NPS Pharmaceuticals have received European regulatory approval for their new short bowel syndrome (SBS) therapy Revestive.

The European Commission has been ratified as a once-daily treatment for the rare, debilitating condition, which can cause malnutrition and diarrhoea, necessitates parenteral nutrition and can lead to life-threatening complications.

Data obtained through the phase III clinical trial Steps revealed that the teduglutide-based therapy helped to reduce reliance on parenteral nutrition among patients, while also demonstrating a strong safety profile.

Revestive has been granted orphan drug designation in the EU and US and will now be made available in Europe through a named patient programme.

Trevor Smith, head of commercial operations in Europe and Canada for Takeda, said: "Teduglutide is the first approved treatment in Europe for this debilitating disease and offers an important new treatment option to patients who are reliant on parenteral nutrition."

This comes after Takeda recently received a Committee for Medicinal Products for Human Use recommendation for approval of the cancer drug Adcetris in Europe.