Takeda's Revestive gets EU clearance for short bowel syndrome

Japan’s largest drugmaker Takeda Pharmaceutical (TSE: 4502) and partner NPS Pharmaceuticals (Nasdaq: NPSP) said yesterday that the European Commission has granted market authorization for Revestive (teduglutide) as a once-daily treatment for adult patients with short bowel syndrome (SBS).

The marketing authorization follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (The Pharma Letter June 25). Following the authorization, Takeda intends to provide patient access to Revestive within Europe initially through a Named Patient Program (NPP).

“Short Bowel Syndrome patients suffer from malnutrition and diarrhoea, and often parenteral nutrition is necessary to maintain life,” said Palle Bekker Jeppesen of the Department of Medical Gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark, adding: “Revestive is a new, unique and important treatment option for our patients and is adding important value to the limited treatment armamentarium.”