19 September 2014 - Healthcare company Eli Lilly and Company (NYSE:LLY) announced on Thursday the receipt of approval for Trulicity (dulaglutide) from the US Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The company intends to launch Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the US later this year.The single-dose pen does not require mixing nor measuring and comes with a no-see, no-handle needle 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.

According to the company, the biologics license application to the US FDA was based on a number of studies of Trulicity used alone or in combination with commonly prescribed diabetes medications. The 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 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. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat, concluded the company.