GattexTreatment for Short Bowel Syndrome
Update: Gattex (teduglutide) Now FDA Approved - December 21, 2012
NPS Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Gattex (teduglutide)
BEDMINSTER, N.J.--(BUSINESS WIRE)--Aug 21, 2012 - NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that its New Drug Application (NDA) for Gattex (teduglutide) will be discussed at the Gastrointestinal Drugs Advisory Committee meeting scheduled for October 16, 2012. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA is December 30, 2012.
Gattex is a novel, recombinant analog of human glucagon-like peptide 2, a peptide involved in normal intestinal function and fluid and nutrient absorption. The proposed indication for Gattex is the treatment of adult patients with short bowel syndrome.
“Short bowel syndrome is a rare and debilitating condition for which a number of patients must currently rely on parenteral nutrition and intravenous fluids to survive, as there are no approved products for long-term treatment,” said Francois Nader, MD, President and Chief Executive Officer of NPS Pharmaceuticals. “We look forward to discussing Gattex with the advisory committee and will continue to work closely with the FDA during its review.”
The Gastrointestinal Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of gastrointestinal diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.
Background materials, when available, or changes to the Advisory Committee meetings calendar can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.
About Short Bowel Syndrome
Short bowel syndrome (SBS) is a highly disabling condition that can impair a patient's quality of life and lead to serious life-threatening complications. SBS typically arises after extensive resection of the bowel due to Crohn's disease, ischemia or other conditions. SBS patients often suffer from malnutrition, severe diarrhea, dehydration, fatigue, osteopenia, and weight loss due to the reduced intestinal capacity to absorb nutrients, water, and electrolytes. The usual treatment for short bowel syndrome is nutritional support, including parenteral nutrition (PN) and/or intravenous (IV) fluids to supplement and stabilize nutritional needs.
Although PN can provide nutritional support for short bowel syndrome patients, it does not improve the body's own ability to absorb nutrients. PN is also associated with serious complications, such as infections, blood clots or liver damage, and the risks increase the longer patients are on PN. Patients on PN often experience a poor quality of life with difficulty sleeping, frequent urination and loss of independence.
About Gattex (teduglutide)
Gattex (teduglutide) is a novel, recombinant analogue of human glucagon-like peptide 2, a 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
Gattex 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. (NASDAQ: NPSP), 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. In June 2012, the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion, recommending the granting of a marketing authorization for teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome (SBS). The company expects the European Commission decision for teduglutide in the third quarter of 2012.
About NPS Pharmaceuticals
NPS Pharmaceuticals is a biopharmaceutical company focused on bringing orphan products to patients with rare disorders and few, if any, therapeutic options. NPS is advancing two late-stage registration programs. A New Drug Application is undergoing FDA review for Gattex®(teduglutide) as a treatment for adult short bowel syndrome (SBS) and a Phase 3 registration study has been completed for Natpara™ (recombinant human parathyroid hormone (rhPTH [1-84]) in adult hypoparathyroidism. NPS' earlier stage pipeline includes two calcilytic compounds, NPSP790 and NPSP795, with potential application in rare disorders involving increased calcium receptor activity, such as autosomal dominant hypocalcemia with hypercalciuria (ADHH). NPS complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Kyowa Hakko Kirin, Nycomed, and Janssen Pharmaceuticals, Inc.
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 Natpara, the risks associated with the company's strategy, as well as other risk factors described in the company's periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this release and NPS undertakes no duty to update this information.
Contact: NPS Pharmaceuticals, Inc.
Susan M. Mesco, 908-450-5516
Posted: August 2012
- FDA Approves Gattex to Treat Short Bowel Syndrome - December 21, 2012
- FDA Advisory Committee Unanimously Recommends Approval of Gattex (teduglutide) for Adults with Short Bowel Syndrome (SBS) - October 16, 2012
- FDA Posts Briefing Documents for Advisory Committee Meeting Reviewing Gattex (teduglutide) for Adult Short Bowel Syndrome - October 12, 2012
- NPS Pharmaceuticals Announces Extension of Action Date for Gattex NDA to December 30, 2012 - August 13, 2012
- NPS Pharmaceuticals Announces FDA Acceptance of New Drug Application for Gattex (teduglutide) for the Treatment of Adult Short Bowel Syndrome (SBS) - January 31, 2012
- NPS Pharmaceuticals Completes Submission of New Drug Application for Gattex (teduglutide) in Adult Short Bowel Syndrome (SBS) - December 1, 2011
- NPS Pharmaceuticals Submits Chemistry, Manufacturing and Controls (CMC) Section of New Drug Application for Gattex - August 18, 2011