The FDA said today that it had approved dulaglutide, Lilly's once-weekly injection to control blood sugar in adults with type 2 diabetes. The drug will be marketed under the brand name of Trulicity.
The FDA said that the safety and efficacy of Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, had been studied in 3,342 type 2 diabetics. The drug can be given as monotherapy or in combination with other diabetes drugs including metformin, sulfonylurea, thiazolidinediones, and prandial insulin. It is not indicated for use in type 1 diabetics, in people with diabetic ketoacidosis, or in people with severe intestinal problems. It should not be used as initial therapy in diabetics who cannot be managed with diet and exercise.
The drug label will contain a boxed warning that in rodents dulaglutide was linked to tumors of the thyroid gland (thyroid C-cell tumors). The FDA says that it is unknown whether in humans the drug can cause these tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC). Trulicity should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2, which may predispose them to MTC.
The most common side effects found in people taking Trulicity were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.
The FDA said that it would require Lilly to perform a number of post-marketing studies, including a cardiovascular outcomes trial, a trial in pediatric patients, and a long term (15 year) registry to identify any increase in the rate of MTC.
Lilly will also be required to implement a Risk Evaluation and Mitigation Strategy (REMS), in which the company will inform physicians and other healthcare professionals about the serious risks linked to the drug.
Trulicity will compete against several other GLP-1 receptor agonists, including exenatide (marketed as Byetta and Bydureon by AstraZeneca), liraglutide (marketed as Victoza by Novo Nordisk), and albiglutide, marketed as Tanzeum by GSK.
