Takeda Pharmaceutical Company Limited (TSE:4502, "Takeda") and NPS Pharmaceuticals, Inc. (NASDAQ: NPSP, "NPS"), jointly announced today that the European Commission (EC) has granted European market authorization for the medicinal product teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome. The marketing authorization follows a positive opinion issued on June 21, 2012, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Following the authorization, Takeda intends to provide patient access to Revestive® within Europe initially through a Named Patient Program (NPP).
“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”
"Short Bowel Syndrome patients suffer from malnutrition and diarrhoea, and often parenteral nutrition is necessary to maintain life," said Professor Palle Bekker Jeppesen, M.D., Ph.D, Department of Medical Gastroenterology, Rigshospitalet, University Hospital of Copenhagen, Denmark. "Revestive is a new, unique and important treatment option for our patients and is adding important value to the limited treatment armamentarium."
"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," said Trevor Smith, Head of Commercial Operations, Europe & Canada, of Takeda.
"The granting of European marketing authorization for teduglutide is welcome news for patients who suffer from short bowel syndrome," said Francois Nader, MD, 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 ApS 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 3 safety and efficacy trial, a double-blind, placebo-controlled study in patients with SBS, who required parenteral nutrition. During the study, 43 patients were randomized to a subcutaneous 0.05 mg/kg/day dose of teduglutide and 43 patients to placebo for up to 24 weeks.
The proportion of patients treated with teduglutide who achieved a 20% to 100% reduction of parenteral nutrition at Week 20 and 24 was significantly higher compared with those receiving placebo.
Source NPS Pharmaceuticals, Inc.