|FDA Unanimously Recommends Approval of Gattex; FDA Tentatively Approves Perrigo's OTC Version Of Omeprazole And Sodium Bicarbonate Capsules|
|By Staff and Wire Reports|
|Tuesday, 16 October 2012 18:55|
NPS Pharmaceuticals (NASDAQ: NPSP), announced the U.S. FDA Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex® (teduglutide) for adults with short bowel syndrome (SBS). The committee's recommendation will be considered by the FDA in its review of the company's New Drug Application (NDA) for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, 2012.
NPS also today reported that five additional patients have successfully achieved independence from parenteral nutrition (PN) and intravenous (IV) fluids while on long-term Gattex® (teduglutide) therapy in STEPS 2, a 24-month open-label study in adult SBS. To date, 12 patients or 14 percent have achieved independence from PN/IV fluids while on Gattex therapy in the ongoing STEPS 2 study.
“The results of today's advisory committee reinforced our belief in the favorable benefit-risk profile of Gattex,” said Francois Nader, MD. “The unique mechanism of Gattex could make it the first and only long-term therapy that treats the underlying cause of this rare disorder by helping patients increase their ability to absorb nutrients and fluids to reduce or even eliminate their dependence on parenteral support. With 14 percent of patients completely eliminating the need for parenteral support in STEPS 2, we believe Gattex could be a life-changing therapy for patients with short bowel syndrome.”
SBS is a serious, complex disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal track to sustain life. SBS is typically treated with PN/IV fluids that do not treat the underlying disorder, which is the body's inability to absorb nutrients and fluids. In addition, long-term use of PN/ IV fluids can be associated with life-threatening complications such as liver damage, serious bloodstream infections, and blood clots.
The Perrigo Company (NASDAQ: PRGO) announced it has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) to market over-the-counter (OTC) omeprazole and sodium bicarbonate capsules 20mg/1100mg, the store brand equivalent to Merck & Co.'s Zegerid OTC®. Perrigo expects to launch the product on the date when market formation occurs.
Zegerid OTC® (omeprazole and sodium bicarbonate capsules 20mg/1100mg), a proton pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the last 12 months.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "Our research and development group worked diligently to achieve this milestone. This is another excellent example of Perrigo's investment and commitment to making quality healthcare more affordable for our customers."
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