New Diabetes Treatment Gets FDA Approval
Tanzeum, a glucagon-like peptide-1 (GLP-1) receptor agonist, was studied alone and in combination with other antidiabetic therapies, including metformin, glimepiride, pioglitazone, and insulin. It mimics the activity of GLP-1 to normalize blood sugar levels.
The safety and efficacy of Tanzeum was evaluated in 8 clinical trials which enrolled over 2,000 patients with type 2 diabetes. Participants in those studies showed improvements in their glycosylated hemoglobin (HbA1c) levels.
The FDA approved Tanzeum with requirements for a Risk Evaluation and Mitigation Strategy (REMS) program to inform healthcare providers about serious risks associated with the drug, including the possibility of thyroid cancer. The FDA is also requiring post-marketing studies evaluating use in pediatric patients, a medullary thyroid carcinoma (MTC) case registry to evaluate cancer risk, and a cardiovascular outcomes trial to observe for potential cardiovascular risk.
For more information call (888) 825-5249 or visit GSK.com.