Eli Lilly and Company announced that the approval of Trulicity (dulaglutide) by the US Food and Drug Administration is the latest treatment option for adults with type 2 diabetes.
Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.
Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. This marks the first approval for Trulicity anywhere in the world. It has also been submitted to the European Medicines Agency and other regulatory bodies.
"We are delighted with the approval of Trulicity. Lilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin," said Enrique Conterno, president, Lilly Diabetes. "Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type 2 diabetes."
The labeling for Trulicity contains a Boxed Warning regarding increased risk for thyroid C-cell tumours based on studies in rats. In rats, dulaglutide caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumours (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Patients should be counseled regarding the risk factors and symptoms of thyroid tumours. See the Important Safety Information at the end of this press release, Prescribing Information and Medication Guide.
The biologics license application to the FDA was based on a number of studies of Trulicity used alone or in combination with commonly prescribed diabetes medications, including metformin, pioglitazone, glimepiride and insulin lispro. These studies included five large phase 3 clinical trials from the Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) clinical development programme. The efficacy of Trulicity was compared to four commonly used type 2 diabetes medicines: metformin, Januvia, Byetta and Lantus.
Trulicity comes in a single-dose pen that does not require mixing, measuring or needle attachment. Trulicity is administered once a week, any time of day, independent of meals, and should be injected subcutaneously in the abdomen, thigh or upper arm. 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," said Dr. David Kendall, vice president, medical affairs, 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."
Diabetes remains one of society's most prevalent diseases. More than 380 million people around the world have diabetes.1 In the US, the disease affects more than 29 million people.2 Type 2 diabetes is the most common, and the number of people with the disease is quickly growing.
Trulicity is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not insulin. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat.
Trulicity comes in a pen that does not require the patient to mix, measure or handle the needle. It can be taken any time of day, with or without meals, and should be injected subcutaneously in the abdomen, thigh or upper arm.