Nycomed files short bowel syndrome treatment
pharmafile | March 28, 2011 | News story | Medical Communications | Nycomed, Revestive, gastrointestinal
Specialist pharma company Nycomed has submitted a novel bowel disease treatment for assessment by European regulators.
The Marketing Authorisation Application (MAA) is for Revestive (teduglutide), a once-daily subcutaneous treatment for short bowel syndrome (SBS).
SBS affects fewer than 10,000 patients in Europe and typically arises after removal of significant portions of the small intestine due to conditions such as Crohn’s disease or ischemia.
Revestive is a recombinant analogue of human glucagon-like peptide 2 (GLP-2), a protein involved in the rehabilitation of the intestinal lining.
It has already received orphan drug status from the European Medicines Agency and FDA.
As well as SBS’s impact on quality of life, it can lead to life-threatening complications as sufferers find their ability to absorb nutrients and fluids is severely impaired.
Patients often suffer from malnutrition, severe diarrhoea, dehydration, fatigue, osteopenia and weight loss and the usual treatment is nutritional support, including parenteral nutrition (PN).
But PN itself does not improve the body’s own ability to absorb nutrients and the treatment is associated with infections, blood clots or liver damage, with risks increasing the longer patients are on it.
The Swiss manufacturer is hopeful because in its trial in SBS patients from Europe, Canada and the US, Revestive reduced the need for such support by at least 20%.
In the trial, 46% of teduglutide-treated patients responded versus 6% of placebo-treated patients, and more reductions in parenteral support were seen in a six month follow-up study.
“The clinical data suggest that teduglutide helps to improve intestinal function in SBS patients, thereby reducing dependence on PN,” said Professor Palle Bekker Jeppesen from the Department of Medical Gastroenterology at the University Hospital of Copenhagen.
“This submission clearly demonstrates Nycomed’s dedicated efforts and strong commitment to bring new and innovative treatments to patients and caregivers addressing a high unmet medical need,” concluded Anders Ullman, Nycomed’s executive vice president R&D.
Adam Hill
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