Press Release
NPS Pharmaceuticals Completes Submission of New Drug Application for GATTEX(R) (teduglutide) in Adult Short Bowel Syndrome (SBS)
GATTEX could become first approved product for the long-term treatment of 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
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.
About Short Bowel Syndrome
Short bowel syndrome, or SBS, is a highly disabling condition that can lead to serious life-threatening complications and impair a patient's quality-of-life. SBS typically arises after extensive resection of the bowel due to Crohn's disease, ischemia or other conditions.
SBS is associated with intestinal failure and the inability to absorb sufficient nutrients and/or fluids through the gastrointestinal tract. Patients with SBS are highly prone to malnutrition, diarrhea, dehydration, and an inability to maintain weight due to the reduced intestinal capacity to absorb macronutrients, water, and electrolytes. As a result, many patients require the chronic use of parenteral nutrition (PN) and intravenous (IV) fluids to supplement their nutritional needs and stabilize their hydration. PN/IV fluids bypass the digestive tract and are delivered directly into the bloodstream through a central venous catheter. Although PN/IV can meet basic nutrition and fluid requirements, it does not improve the body's ability to absorb nutrients.
The long-term use of PN/IV fluids is associated with shortened life span and life-threatening complications such as blood clots and liver damage. The development of PN-associated liver disease predisposes patients to an increased incidence of sepsis, increased mortality rates, and the potential to develop irreversible liver damage. Patients on parenteral support often experience a poor quality of life with difficulty sleeping, frequent urination, and loss of independence.
There are an estimated 10,000 to 15,000 SBS patients in the U.S. who are dependent on parenteral nutrition and intravenous fluids.
About GATTEX® (teduglutide)
GATTEX (teduglutide) is a novel, recombinant analog 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 short bowel syndrome.
Teduglutide has received orphan drug designation for the treatment of
SBS from the
In
About
“NPS”, “NPS Pharmaceuticals”, and “GATTEX” are the company’s registered trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.
Statements made in this press release, which are not historical in
nature, constitute forward-looking statements for purposes of the safe
harbor provided by the Private Securities Litigation Reform Act of 1995.
These statements are based on the company's current expectations and
beliefs and are subject to a number of factors and uncertainties that
could cause actual results to differ materially from those described in
the forward-looking statements. Risks associated to the company’s
business include, but are not limited to, the risks associated with any
failure by the company to successfully complete its preclinical and
clinical studies within the projected time frames or not at all, the
risk of not gaining marketing approvals for GATTEX and NPSP558, the
risks associated with the company’s strategy, as well as other risk
factors described in the company’s periodic filings with the
Source:
NPS Pharmaceuticals, Inc.
Susan M. Mesco, +1 908-450-5516
smesco@npsp.com
The reports filed by NPS with the Securities and Exchange Commission and the news releases issued by NPS and posted on this website are current only as of the dates on which they were filed or issued by NPS. Therefore, the contents of these reports and releases can become outdated. We make no commitment, and disclaim any duty, to update these reports and releases. We do not warrant the accuracy or completeness of these materials or the reliability of any advice, opinion, statement or other information displayed or distributed through the website. Readers acknowledge that any reliance on these reports, releases, advice, opinions, statements, or information are at the reader’s sole risk.