The U.S. Food and Drug Administration has approved Trulicity, which will be used as a new treatment for type 2 diabetes.
The subcutaneous injection should be used once weekly and is said to improve glycemic control (blood sugar levels), with a little diet control and exercise, in adults with type 2 diabetes.
"Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal," Dr. Mary Parks, deputy director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, said in a press statement. "Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type 2 diabetes."
The effectiveness and safety of the drug was tested in six clinical trials, which included more than 3,342 patients with type 2 diabetes. Researchers found that the patients receiving the drug saw an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).
The drug also comes with a boxed warning cautioning people that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Trulicity but that it is unknown whether Trulicity causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC) in humans. However, patients with a personal or family history of MTC and those with multiple endocrine neoplasia syndrome type 2 should refrain from using the drug.
Trulicity received approval from the FDA with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Trulicity. A few post-marketing tests still need to be conducted on the drug. These include:
- a clinical trial to evaluate dosing, efficacy and safety in pediatric patients;
- a study to assess potential effects on sexual maturation, reproduction and CNS development and function in immature rats;
- a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity;
- a clinical trial comparing Trulicity with insulin glargine on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment; and
- a cardiovascular outcomes trial to evaluate the risk of Trulicity in patients with high baseline risk of cardiovascular disease.
