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PHILADELPHIA, July 29, 2014 /PRNewswire/ -- GSK (LSE/NYSE: GSK) today announced that once-weekly Tanzeum (albiglutide), a prescription injectable treatment for type 2 diabetes in adults, as an adjunct to diet and exercise, is now available in pharmacies throughout the U.S.
Cheryl MacDiarmid, Vice President of GSK's General Medicine business said, "With approximately 21 million adults diagnosed with diabetes in the US1, and up to 95 percent of those patients living with type 2 diabetes, we're excited that for the appropriate patients Tanzeum is now available as a treatment option for healthcare professionals."
Tanzeum, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a once weekly option for patients, in combination with some other glucose-lowering medicines. The medicine was approved by the FDA on April 15, 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Tanzeum is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. Tanzeum is not a substitute for insulin in these patients. Tanzeum has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of Tanzeum is not recommended in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin.
MacDiarmid continued, "GSK has a commitment to taking a responsible approach to pricing. Tanzeum has been priced in line with this commitment."
Diabetes is a global epidemic, affecting 382 million individuals globally, almost 21 million of whom are in adults the US.1,2 Up to 95% of these patients have type 2 diabetes.1 Type 2 diabetes is a life-long, progressive and, in some cases, preventable condition characterized by high blood sugar levels, known as hyperglycemia. A lack of physical activity, obesity, increasing age, high blood pressure and genetics are known risk factors that can contribute to the development of type 2 diabetes3,4
About Tanzeum (albiglutide)
Tanzeum is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of use
Tanzeum is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Tanzeum has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Tanzeum is not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Tanzeum is not a substitute for insulin in these patients. Tanzeum has not been studied in patients with pre-existing severe gastrointestinal disease. Tanzeum has not been studied in combination with prandial insulin.
Full US Prescribing Information, including BOXED WARNING, Medication Guide and Instructions for Use is available at us.gsk.com. In addition, a copy of the label may be requested from the GSK Media or Investor Relations contacts listed in the "GSK Inquiries" section at the end of this document.
Tanzeum has been approved with a Risk Evaluation and Mitigation Strategy (REMS), required by the FDA to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis. A non-promotional factsheet, reviewed by the FDA, with more detailed safety information is available at www.TANZEUMREMS.com.
Important safety information
Warning: Risk of thyroid C-cell tumors. Thyroid C-cell tumors have been observed in rodent studies with glucagon-like peptide-1 (GLP-1) receptor agonists at clinically relevant exposures. It is unknown whether Tanzeum causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Tanzeum. Patients should be counseled regarding the risk and symptoms of thyroid tumors.
Hypersensitivity: Tanzeum is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.
Warnings and precautions
Risk of Thyroid C-cell Tumors: Tanzeum is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the risk for MTC with the use of Tanzeum and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Patients with thyroid nodules noted on physical examination or neck imaging should be referred to an endocrinologist for further evaluation. Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Tanzeum. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin testing for MTC and a high background incidence of thyroid disease. If serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.
Acute Pancreatitis: In clinical trials, acute pancreatitis has been reported in association with Tanzeum. After initiation of Tanzeum, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, promptly discontinue Tanzeum. If pancreatitis is confirmed, Tanzeum should not be restarted. Tanzeum has not been studied in patients with a history of pancreatitis to determine whether these patients are at increased risk for pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: The risk of hypoglycemia is increased when Tanzeum is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin. Therefore, patients may require a lower dose of sulfonylurea or insulin to reduce the risk of hypoglycemia in this setting.
Hypersensitivity Reactions: Across 8 Phase III clinical trials, a serious hypersensitivity reaction with pruritus, rash, and dyspnea occurred in a patient treated with Tanzeum. If hypersensitivity reactions occur, discontinue use of Tanzeum; treat promptly per standard of care and monitor until signs and symptoms resolve.
Renal Impairment: In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events were reported in patients without known underlying renal disease. A majority of reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. In a trial of Tanzeum in patients with renal impairment, the frequency of such gastrointestinal reactions increased as renal function declined. Because these reactions may worsen renal function, use caution when initiating or escalating doses of Tanzeum in patients with renal impairment. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.
Macrovascular Outcomes: There have been no clinical trials establishing conclusive evidence of macrovascular risk reduction with Tanzeum or any other antidiabetic drug.
The most common adverse reactions, excluding hypoglycemia, reported in >/=5% of patients treated with Tanzeum and more commonly than in patients treated with placebo, are: upper respiratory tract infection (14.2 vs 13.0); diarrhea (13.1 vs 10.5); nausea (11.1 vs 9.6); injection site reaction (10.5 vs 2.1); cough (6.9 vs 6.2); back pain (6.7 vs 5.8); arthralgia (6.6 vs 6.4); sinusitis (6.2 vs 5.8); influenza (5.2 vs 3.2).
Tanzeum delays gastric emptying and may impact absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Tanzeum
Use in specific populations
Safety and effectiveness of Tanzeum have not been established in pediatric patients (younger than 18 years).
Tanzeum and Eperzan® are trademarks of the GlaxoSmithKline group of companies.
GSK one of the world's leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.
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