Quantcast
Published On: Wed, Apr 16th, 2014

Diabetes drug, Tanzeum, receives FDA approval

PRESS RELEASE

The U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

Global Dispatch 200x119Type 2 diabetes affects approximately 24 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

“Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”

Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Tanzeum has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, glimepiride, pioglitazone, and insulin. Tanzeum should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or as first-line therapy for patients who can’t be managed with diet and exercise.

Tanzeum has a Boxed Warning to warn that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Tanzeum should not be used in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (a disease where patients have tumors in more than one gland in their body and that predisposes them to MTC).

The FDA is requiring the following post-marketing studies for Tanzeum:

  • a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients;
  • a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum;
  • a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.

In clinical trials, the most common side effects observed in patients treated with Tanzeum were diarrhea, nausea, and injection site reactions.

The FDA approved Tanzeum with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with Tanzeum.

Tanzeum is manufactured by GlaxoSmithKline, L.L.C., Wilmington, Del.

About the Author

- The generic Dispatch designation, used primarily for press releases or syndicated content, but may be used for guest author requesting a generic nomenclature

Displaying 24 Comments
Have Your Say
  1. […] part of any regime to improve diabetes. Also note that drugs do have side effects as …Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchFDA approves new type 2 diabetes drugHealth24.comDiabetes drug, Tanzeum, gets FDA […]

  2. […] Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchThe U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Global Dispatch 200×119 Type 2 diabetes affects approximately …FDA Approves New Drug to Treat Type 2 DiabetesHeadlines & Global NewsDiabetes drug, Tanzeum, gets FDA approvalDelhi Daily NewsUS approves injectable diabetes drug from GlaxoWFAAeMaxHealth -MedPage Todayall 70 news articles » […]

  3. […] untreated. Even though there are several diabetes medications out there, researchers …Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchFDA approves new type 2 diabetes drugHealth24.comFDA Approves New Drug to Treat […]

  4. […] untreated. Even though there are several diabetes medications out there, researchers …Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchFDA approves new type 2 diabetes drugHealth24.comFDA Approves New Drug to Treat […]

  5. […] untreated. Even though there are several diabetes medications out there, researchers …Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchFDA approves new type 2 diabetes drugHealth24.comFDA Approves New Drug to Treat […]

  6. […] = "0000CC"; ch_color_border = "0000FF"; ch_color_text = "000000"; ch_color_bg = "FFFFFF"; Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchFDA approves new type 2 diabetes drugHealth24.comHeadlines & Global […]

  7. […] part of any regime to improve diabetes. Also note that drugs do have side effects as …Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchFDA approves new type 2 diabetes drugHealth24.comDiabetes drug, Tanzeum, gets FDA […]

  8. […] Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchThe U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Global Dispatch 200×119 Type 2 diabetes affects approximately …FDA Approves New Drug to Treat Type 2 DiabetesHeadlines & Global NewsDiabetes drug, Tanzeum, gets FDA approvalDelhi Daily NewsUS approves injectable diabetes drug from GlaxoWFAAeMaxHealth -MedPage Todayall 70 news articles » […]

  9. […] via Diabetes drug, Tanzeum, receives FDA approval – The Global Dispatch. […]

  10. […] part of any regime to improve diabetes. Also note that drugs do have side effects as …Diabetes drug, Tanzeum, receives FDA approvalThe Global Dispatch ch_client = "fryedaddy"; ch_width = 300; ch_height = 250; ch_type = "mpu"; […]

  11. […] Diabetes drug, Tanzeum, receives FDA approval […]

  12. […] Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchThe U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Global Dispatch 200×119 Type 2 diabetes affects approximately …FDA Approves New Drug to Treat Type 2 DiabetesHeadlines & Global NewsFDA approves new drug for Type 2 DiabetesDelhi Daily NewsFDA approves once a week diabetes injection: Could you take the drug?eMaxHealthWFAA -MedPage Todayall 69 news articles » […]

  13. […] Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchThe U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Global Dispatch 200×119 Type 2 diabetes affects approximately …FDA Approves New Drug to Treat Type 2 DiabetesHeadlines & Global NewsFDA approves new drug for Type 2 DiabetesDelhi Daily NewsFDA approves once a week diabetes injection: Could you take the drug?eMaxHealthWFAA -MedPage Todayall 68 news articles » […]

  14. […] Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchThe U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Global Dispatch 200×119 Type 2 diabetes affects approximately …FDA Approves New Drug to Treat Type 2 DiabetesHeadlines & Global NewsFDA approves new drug for Type 2 DiabetesDelhi Daily NewsFDA approves once a week diabetes injection: Could you take the drug?eMaxHealthWFAA -MedPage Todayall 68 news articles » […]

  15. […] Diabetes drug, Tanzeum, receives FDA approvalThe Global DispatchThe U.S. Food and Drug Administration Tuesday approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Global Dispatch 200×119 Type 2 diabetes affects approximately …FDA Approves New Drug to Treat Type 2 DiabetesHeadlines & Global News ch_client = "fryedaddy"; ch_width = 300; ch_height = 250; ch_type = "mpu"; ch_sid = "Chitika Default"; ch_color_site_link = "0000CC"; ch_color_title = "0000CC"; ch_color_border = "0000FF"; ch_color_text = "000000"; ch_color_bg = "FFFFFF"; FDA approves new drug for Type 2 DiabetesDelhi Daily NewsFDA approves once a week diabetes injection: Could you take the drug?eMaxHealthWFAA -MedPage Todayall 68 news articles » […]

Leave a comment

XHTML: You can use these html tags: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>



At the Movies