FDA approves Trulicity for treatment of Type 2 Diabetes- Eli Lilly

Trulicity (dulaglutide), a once-weekly subcutaneous injection, was approved on 18 September 2014 by the FDA and is the latest Eli Lilly and Company 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.