NPS Pharmaceuticals Inc., completes the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Gattex (teduglutide).
NPS, a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, has also asked the FDA to designate the application for Priority Review, which is given to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. Gattex is a novel, recombinant analogue of human glucagon-like peptide 2, a peptide involved in gastrointestinal regeneration and repair, which NPS has been developing for the treatment of adults with short bowel syndrome or SBS, a highly disabling and potentially life-threatening chronic disorder.
Gattex (teduglutide) is a novel, recombinant analogue of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. The lead indication for Gattex is treatment of adults with short bowel syndrome. NPS has reported findings from completed studies in which Gattex was well tolerated and effectively reduced parenteral nutrition and intravenous fluid volume requirements in subjects with adult SBS.
“The submission of this NDA is an important milestone for NPS as it brings us one step closer to bringing Gattex to market and to making a clinically-meaningful impact on the lives of SBS patients who are suffering from this debilitating disorder,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “SBS patients are typically tethered to parenteral nutrition many days per week, which has been linked to life-threatening complications, a shortened life span, and reduced quality of life. Gattex could represent the first FDA-approved therapy indicated for the long-term treatment of this condition, potentially reducing or even eliminating a patient’s dependence on intravenous nutrition and fluid.”
The company’s SBS clinical development program represents the largest and most comprehensive to date. The information in the NDA is derived from 14 completed and one ongoing clinical study. A total of 566 subjects have been treated with teduglutide. Of the 566 subjects treated with teduglutide, 299 subjects were treated in the clinical pharmacology studies, 94 subjects in Crohn’s Disease studies, and 173 subjects in the SBS efficacy and safety studies. Seventy-five SBS subjects have more than 12 months of exposure to Gattex.
Teduglutide has received orphan drug designation for the treatment of SBS from the US Food and Drug Administration (FDA) and the European Medicines Agency.
In March 2011, Nycomed, a Takeda Company since end of September 2011, submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for clearance to market teduglutide (Revestive) as a once-daily subcutaneous treatment for short bowel syndrome. In 2007, NPS granted Nycomed the rights to develop and commercialize teduglutide outside the United States, Canada and Mexico. NPS retains all rights to teduglutide in North America.