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FDA Approves Gattex® (teduglutide [rDNA Origin]) For Injection For The Treatment Of Adult Short Bowel Syndrome

About Gattex ® (teduglutide [rDNA origin]) for Injection

Gattex ® (teduglutide [rDNA origin] for Injection) is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. Gattex ® 0.05 mg/kg/d (teduglutide [rDNA origin] for Injection) is indicated for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. Significant reductions in mean PN/IV infusion volume from baseline to end of treatment were seen in the Phase 3 studies of Gattex. In addition, some patients were able to achieve independence from PN/IV support during these trials. The most common side effects of Gattex include stomach area (abdomen) pain or swelling, skin reaction where the injection was given, nausea, headache, cold or flu like symptoms, vomiting, and holding too much fluid in the body (swelling of face, ankles, hands or feet).

Gattex has received orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and the FDA.

In 2007, NPS granted Takeda GmbH, the rights to develop and commercialize teduglutide outside the United States, Canada, Mexico and Israel. NPS retains all rights to teduglutide in North America. The European Commission granted European market authorization on August 30, 2012 for the medicinal product teduglutide (trade name in Europe: Revestive®) as a once-daily treatment for adult patients with short bowel syndrome.

Teduglutide was discovered by Daniel J. Drucker, MD, currently a senior scientist based in the Samuel Lunenfeld Research Institute at Mt. Sinai Hospital, University of Toronto, in Toronto, Canada. NPS has an exclusive license agreement with Dr. Drucker for teduglutide and its therapeutic uses.

Important Safety Information (ISI)

Gattex has been associated with serious risks including:

  • Neoplastic growth. There is a risk for acceleration of neoplastic growth. Colonoscopy of the entire colon with removal of polyps must be done before initiating treatment with Gattex and is recommended after 1 year. Subsequent colonoscopies should be done as needed, but no less frequently than every 5 years. In case of intestinal malignancy discontinue Gattex. The clinical decision to continue Gattex in patients with active non-gastrointestinal malignancy should be made based on risk and benefit considerations.
  • Intestinal obstruction. In patients who develop obstruction, Gattex should be temporarily discontinued pending further clinical evaluation and management.
  • Biliary and pancreatic disease. Patients should undergo laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) before starting Gattex. Subsequent laboratory tests should be done every 6 months. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with Gattex should be reassessed.
  • Fluid overload. There is a potential for fluid overload while on Gattex. If fluid overload occurs, especially in patients with cardiovascular disease, parenteral support should be appropriately adjusted, and Gattex treatment reassessed.

Prescribers should select the appropriate patients to receive Gattex in accordance with the approved prescribing information, discuss the benefits and risks of Gattex with patients, and monitor patients as specified in the approved prescribing information and report adverse events to NPS’ Gattex information line at 1-855-5GATTEX (1-855-542-8839) or event/product complaint line at 1-855-215-5550.

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