NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, today announced that the U.S. Food and Drug Administration (FDA) has approved Gattex ® (Teduglutide [rDNA origin]) for Injection, for subcutaneous use for the treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. Gattex will be available in the first quarter of 2013.
“Gattex is a ground-breaking therapy that has been evaluated in the largest clinical program to date in short bowel syndrome,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “We are very excited about the opportunity to help SBS patients by offering this first-in-class therapy. The approval of Gattex is a crowning achievement for our company and the catalyst for our transformation into a premier orphan drug business. We are prepared for a successful launch based on productive interactions with payers, methodical patient identification, and the strategic development of our field-based commercial infrastructure. We have also launched NPS Advantage, our free support program that includes, care coordinators who will work closely with patients to help them understand the clinical characteristics of Gattex and navigate the reimbursement landscape.”
SBS is a serious, complex disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal tract to sustain life. SBS patients are commonly infused with PN/IV five to seven nights per week for up to 10 to 12 hours at a time, and in extreme cases, some patients could receive PN/IV for 24 hours a day. Long-term use of PN/ IV fluids can be associated with life-threatening complications such as liver damage, serious bloodstream infections, and blood clots.
Gattex is the first major long-term treatment advance for SBS in nearly 40 years. The unique mechanism of action of Gattex enhances gastrointestinal absorption. In Phase 3 studies, significant reductions in PN/IV volume and infusion days per week were achieved from pre-treatment baseline. In addition, some patients achieved independence from PN/IV support.