Lilly Launches Trulicity For Diabetes In U.S.
Eli Lilly & Co. announced that its recently approved diabetes drug Trulicity (dulaglutide) is now available in pharmacies across the U.S.
Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) that, when paired with diet and exercise, can help improve glucose levels in patients with Type 2 diabetes. The drug is available as a single-dose pen, eliminating the need to mix, measure, or handle a needle. The U.S. Food and Drug Administration (FDA) approved Trulicity in September this year based on positive results from safety and efficacy trials.
Diabetes affects an estimated 382 people around the world, including 29 million in the U.S. Of these, Type 2 diabetes is responsible for 90 to 95 of all diabetes cases. Dr. Laura Fernandez, senior medical advisor at Lilly Diabetes, said, “Some adults with Type 2 diabetes find that diet, exercise, and oral medicines aren't enough to meet their treatment goals. Trulicity may be an option for them as it has demonstrated proven glycemic control, only has to be taken once weekly, and comes in an easy-to-use pen.”
Trulicity comes with a boxed warning informing physicians and patients that thyroid C-cell tumors have developed in rat studies involving the drug, though there are no data directly linking Trulicity to the adverse event in human studies. Lilly has been required by the U.S. Food and Drug Administration (FDA) to conduct post-marketing studies for Trulicity which will include follow-up studies on medullary thyroid carcinoma (MTC) incidence and cardiovascular outcome risk related to use of dulaglutide.
Trulicity is not indicated for first-line treatment of diabetes patients whose disease is inadequately controlled on diet and exercise. The drug is not a substitute treatment for Type 1 diabetes mellitus or diabetic ketoacidosis. It is not also meant to be substitute for insulin or basal insulin.
The company said other regulatory applications for Trulicity as treatment for T2D are undergoing review in the EU and other countries.