Updated on 5 September 2012
"The granting of European marketing authorization for teduglutide is welcome news for patients who suffer from short bowel syndrome," said Dr Francois Nader, president and chief executive officer of NPS Pharmaceuticals. "We look forward to supporting our partner Takeda as it works to launch this important therapy for patients in Europe."
The marketing authorization will be held by Nycomed Danmark and is valid in the current EU member states. National approvals are expected in Iceland and Norway within 30 days. It is based on data obtained from the STEPS pivotal phase III safety and efficacy trial, a double blind, placebo controlled study in patients with SBS, who required parenteral nutrition.