The European Commission (EC) has granted marketing authorization for the medicinal product teduglutide (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 Pharmaceutical Company intends to provide patient access to Revestive within Europe initially through a Named Patient Program (NPP)
Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2 (GLP-2), a naturally occurring protein involved in the rehabilitation of the intestinal lining. It has been developed to reduce dependence on parenteral nutrition (PN) in adult patients with short bowel syndrome (SBS). Two phase 3 studies of teduglutide demonstrated a favorable safety profile and significant reductions in mean PN volume from baseline to end of treatment. In addition some patients were able to be weaned off PN and continue their life without parenteral support.
“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 authorisation 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, (63% versus 30%, p=0.002). Treatment with teduglutide resulted in a 4.4 litre/week reduction in parenteral nutrition requirements versus 2.3 litre/week for placebo at 24 weeks (p<0.001). Twenty-one patients treated with teduglutide (54%) versus nine on placebo (23%) achieved at least a one day reduction in parenteral nutrition administration (p=0.005). Teduglutide was well-tolerated in the doses, frequency, and duration of treatment used in this study.
Teduglutide has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA).
In 2007, NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, granted Nycomed the rights to develop and commercialize teduglutide outside the United States, Canada and Mexico and Israel. NPS retains all rights to teduglutide in North America. NPS submitted a new drug application for teduglutide to the US Food and Drug Administration (FDA) in November 2011. Teduglutide is known as Gattex in the US.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine.
NPS Pharmaceuticals is a biopharmaceutical company focused on bringing orphan products to patients with rare disorders and few, if any, therapeutic options.