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INDIANAPOLIS — Eli Lilly and Co. has been cleared to market Trulicity, a medication for type 2 diabetes.
Lilly said Thursday Trulicity (dulaglutide) has been approved by the Food and Drug Administration an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The medication isn’t recommended as a first-line therapy for patients inadequately controlled on diet and exercise, the company noted.
Not insulin, Trulicity acts like the natural hormone GLP-1 (glucagon-like peptide-1) to help patients’ bodies release their own insulin when they eat.
Trulicity comes in a pen that doesn’t require the patient to mix, measure or handle the needle. It can be taken any time of day, with or without meals, and is directed to be injected subcutaneously in the abdomen, thigh or upper arm.
"We are delighted with the approval of Trulicity. Lilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin," stated Enrique Conterno, president of Lilly Diabetes. "Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type 2 diabetes."
Lilly said it plans to make Trulicity 0.75-mg and 1.5-mg single-dose pens available for adults in the United States later this year. The company added that the FDA clearance marks the first approval for Trulicity anywhere in the world. The product has also been submitted to the European Medicines Agency and other regulatory bodies.
The recommended starting dose is 0.75 mg, which can be increased to 1.5 mg dose for patients who need additional blood sugar control.
"Type 2 diabetes is a progressive disease, and many patients have not reached their treatment goals," commented Dr. David Kendall, vice president of medical affairs for Lilly Diabetes. "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."
