This marks the first approval for Trulicity anywhere in the world
Trulicity (dulaglutide) was approved by USFDA, which is the latest Eli Lilly's treatment option for adults with type 2 diabetes.
Diabetes remains one of society's most prevalent diseases. More than 380 million people around the world suffer from diabetes.
Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Trulicity comes in a single-dose pen that does not require mixing, measuring or needle attachment. It 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.
This drug 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. It is also not a substitute for insulin and has not been studied in combination with basal insulin.
Lilly said in a statement that this drug 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.
