Nycomed has filed teduglutide, its investigational treatment for a rare bowel disease, with regulators in Europe.
The privately-held Swiss firm has submitted a marketing authorisation application to the European Medicines Agency for Revestive (teduglutide) as a once-daily subcutaneous treatment for short bowel syndrome (SBS). Teduglutide is a novel, recombinant analogue of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
The submission is based on a study in SBS patients from Europe, Canada and the USA and demonstrated that teduglutide was effective in reducing the need for parenteral support (providing intravenous nutrition) by at least 20%. Some 46% of teduglutide-treated patients responded versus 6% for those on placebo and further reductions in parenteral support were seen in a six month follow-up study.
SBS affects just four per one million inhabitants in Europe and is characterised by a severely impaired ability to absorb nutrients and fluids in people who have had a significant portion of their small intestine removed. It typically arises after surgical removal of the bowel due to Crohn's disease, ischemia or other conditions.
Nycomed quoted Palle Bekker Jeppesen of the University Hospital of Copenhagen as saying that SBS patients suffer from malnutrition and diarrhoea, "and often parenteral nutrition is necessary to maintain life". He added that the clinical data suggest that teduglutide gives them "better fluid and energy absorption and potentially improving their quality of life", saying that "the addition of teduglutide to the limited treatment armamentarium may increase the awareness of this debilitating condition".
Revestive has received orphan drug designation in Europe.