Biotech
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`FDA approves Gattex to treat short bowel syndrome
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`by Jennifer Levin | Dec 21, 2012 12:10pm
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`FDA NEWS RELEASE: FDA approves Gattex to treat short bowel syndrome
`For Immediate Release: Dec. 21, 2012
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`The U.S. Food and Drug Administration today approved Gattex (teduglutide) to treat adults with short
`bowel syndrome (SBS) who need additional nutrition from intravenous feeding (parenteral nutrition).
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`SBS is a condition that results from the partial or complete surgical removal of the small and/or large
`intestine. Extensive loss of the small intestine can lead to poor absorption of fluids and nutrients from
`food needed to sustain life. As a result, patients with SBS often receive parenteral nutrition.
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`Gattex is an injection administered once daily that helps improve intestinal absorption of fluids and
`nutrients, reducing the frequency and volume of parenteral nutrition. It is the third FDA-approved drug
`to treat adults with SBS receiving nutritional support. Zorbtive (somatropin) and Nutrestore (glutamine)
`were approved in 2003 and 2004, respectively.
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`"Today's approval expands the available treatment options for patients with this life-threatening
`condition," said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA's
`Center for Drug Evaluation and Research. "Because Gattex may cause other serious health conditions,
`it is critical that patients and health care professionals understand the drug's potential and known safety
`risks."
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`Patients treated with Gattex have a potential increased risk of developing cancer and abnormal growths
`(polyps) in the intestine, obstructions in the intestine, gallbladder disease, biliary tract disease and
`pancreatic disease. To ensure that the benefits of Gattex outweigh the potential risks, the drug is being
`approved with a Risk Evaluation and Mitigation Strategy, consisting of a communication plan and
`training for prescribers.
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`Gattex's safety, efficacy and tolerability were evaluated in two clinical trials and two extension studies.
`CFAD Exhibit 1085
`Patients in the trials were randomly assigned to receive Gattex or a placebo.
`CFAD v. NPS
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`IPR2015-01093
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`The clinical trials were designed to measure the number of patients who achieved at least 20 percent
`reduction in the volume of weekly parenteral nutrition after 20 and 24 weeks of treatment (clinical
`response). Forty-six percent and 63 percent of patients treated with Gattex achieved clinical response,
`versus 6 percent and 30 percent of patients treated with placebo.
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`The trials also measured the mean reduction in the volume of parenteral nutrition (liters per week) after
`24 weeks of treatment. Results showed a mean reduction in parenteral nutrition of 2.5 L/week and 4.4
`L/week in Gattex-treated patients, compared with 0.9 L/week and 2.3 L/week in placebo-treated
`patients.
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`The extension studies followed patients treated with Gattex in the clinical trials for an additional 28
`weeks. Patients experienced a 4.9 L/week and 5.2 L/week mean reduction in parenteral nutrition after
`one year of continuous Gattex treatment. Six patients in the extension studies were weaned off
`parenteral nutrition while on Gattex.
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`The most common side effects of Gattex identified in clinical trials were abdominal pain, injection site
`reactions, nausea, headaches, abdominal distension and upper respiratory tract infection.
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`To study Gattex's long-term safety, the FDA is requiring a postmarket study of SBS patients treated with
`the drug in a routine clinical setting to further evaluate the drug's potential increased risk to cause
`colorectal cancer and other conditions. Patients in this study will be followed for at least 10 years.
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`Gattex is marketed by Bedminster, N.J.-based NPS Pharmaceuticals. Zorbtive is marketed by EMD
`Serono, based in Rockland, Mass. and Nutrestore is marketed by Torrance, Calif.-based Emmaus
`Medical Inc.
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`For more information:
`
`FDA Approved Drugs: Questions and Answers
`
`FDA: Drug Innovation
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`NIH: Short Bowel Syndrome
`
`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public
`health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and
`other biological products for human use, and medical devices. The agency also is responsible for the
`safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off
`electronic radiation, and for regulating tobacco products.
`
`Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
`Consumer Inquiries: 888-INFO-FDA
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`Read More:
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`About the Author
`ennifer Levin
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