FDA Green Lights Lilly's T2D Drug Trulicity

Eli Lilly & Co. announced that the U.S. Food and Drug Administration (FDA) has approved Trulicity (dulaglutide) as an adjunct treatment for adults with Type 2 diabetes.

Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is a hormone that helps normalize blood sugar levels of patients with diabetes. The drug is indicated as an adjunct treatment to proper diet and exercise in patients with T2D. The FDA approval is based on positive results from safety and efficacy trials involving 3,342 patients. Results show that those treated with Trulicity enhanced their blood sugar control and reduced their hemoglobin A1c (HbA1c) level.

Mary Parks, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said, “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.”

“Type 2 diabetes is a progressive disease, and many patients have not reached their treatment goals. Trulicity is a new, non-insulin, injectable option that was designed with the patient in mind. It will be available in a once-weekly pen and does not require mixing, measuring, nor needle handling,” said Dr. David Kendall, VP of medical affairs at Lilly Diabetes.

The drug will be distributed with a boxed warning stating that thyroid C-cell tumors have been observed in rat studies involving Trulicity, though it remains unknown whether the drug directly caused the tumors. The FDA has required Lilly to conduct post-marketing studies for the drug. These include follow-up studies on cardiovascular outcome risk, medullary thyroid carcinoma (MTC) incidence related to the use of the drug, and potential effects on sexual maturation and reproduction in immature rats.

Lilly said it intends to launch Trulicity in the U.S. this year. Regulatory applications for the drug are undergoing review in the EU and other countries.