Healthcare company Eli Lilly and Company (NYSE:LLY) reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) to expand the label of once-weekly Trulicity (dulaglutide) to include 3.0 mg and 4.5 mg doses for treating type 2 diabetes based on data from AWARD-11.

The phase 3 trial showed that the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg in people with type 2 diabetes. The additional doses of Trulicity will be available in US pharmacies in late September.

The AWARD-11 trial evaluated the safety and efficacy of additional doses of Trulicity (3.0 mg and 4.5 mg) compared to Trulicity 1.5 mg, using two different statistical approaches. The primary objective of the study was to demonstrate that a once-weekly investigational dulaglutide dose (3.0 mg and/or 4.5 mg) was superior to the approved 1.5 mg dose, as measured by A1C reduction from baseline, at 36 weeks in people with inadequately controlled type 2 diabetes on concomitant metformin therapy.

Results from AWARD-11 are also under review by the European Medicines Agency's Committee for Medicinal Products for Human Use, with an opinion on whether to recommend approval by the European Commission expected this year.

Trulicity is a prescription medicine for adults with type 2 diabetes used to improve blood sugar (glucose) and to reduce the risk of major cardiovascular events such as death, heart attack or stroke in people who have heart disease or multiple cardiovascular risk factors.