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FDA approves new drug for people with type 2 diabetes

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

Type 2 diabetes affects approximately 24 million people and accounts for more than 90% of diabetes cases diagnosed in the U.S. Over time, hyperglycemia 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,” Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a news release. “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 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 HbA1c levels.

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 or those with diabetic ketoacidosis, or as first-line therapy for patients whose diabetes can’t be managed with diet and exercise.

Carries risks

A boxed warning alerts Tanzeum users that 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, 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.

The FDA is requiring a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients; a medullary thyroid carcinoma case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum; and a cardiovascular outcomes trial 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, which consists of a communication plan to inform healthcare providers about the serious risks associated with Tanzeum.

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By | 2014-04-16T00:00:00-04:00 April 16th, 2014|Categories: Uncategorized|0 Comments

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