On Tuesday The U.S. Food and Drug Administration finally approved Tanzeum subcutaneous injection to control glycemic in a better way, with exercise and diet, in adults who have been diagnosed with diabetes type 2.
This disease affects almost 24m people and probably more than 90% diabetes patients diagnosed in U.S. After passage of time, high level of blood sugar can rise the risk for major complications for example kidney and nerve damage, heart disease and blindness.
“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 receptor agonist, hormone helps to become a normal blood sugar levels. Effectiveness and safety of the drug were evaluated in 8 clinical trials regarding more than two thousand cases with type 2 diabetes. In the trials patients participating were to be seen an improvement in their HbA1c (a measurement of blood sugar control).
Patients who participated in the clinical trials were observed having side effects such as nausea, diarrhea and some injection site reactions.
Approval of Tanzeum by FDA complys with a Risk Evaluation and Mitigation Strategy (REMS). This means that a communication plan will be in place to inform the general health care physicians and providers about the side effects and risks related to Tanzeum.
Tanzeum at the moment is manufactured solely through GlaxoSmithKline, LLC., in Wilmington, Delaware.