Lilly drug receives additional FDA approval

INDIANAPOLIS (Inside INdiana Business) — The U.S. Food and Drug Administration has approved two additional doses of a drug developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The company says a Phase 3 trial showed the additional doses of Trulicity led to further benefits for people with Type 2 diabetes.

The AWARD-11 study, Lilly says, compared 3.0 mg and 4.5 mg doses with the original 1.5 mg dose and showed the additional doses led to greater improvement in A1C and body weight reduction.

“The FDA’s decision to approve the additional doses of Trulicity is a positive step forward for people living with type 2 diabetes and their care teams,” said Dr. Juan Pablo Frias, medical director and principal investigator for the National Research Institute. “This progressive condition can require different treatment approaches over time, and findings from AWARD-11 showed the additional doses of Trulicity can lead to further A1C and weight reductions for people with type 2 diabetes whose current treatment may no longer be meeting their needs.”

Lilly says with the FDA approval, the additional doses of Trulicity will be available in U.S. pharmacies later this month.

The company adds the results from the AWARD-11 study are also under review by the European Medicines Agency’s Committee for Medicinal Products for Human Use. An opinion on whether to recommend approval by the European Commission is expected later this year.

You can read more about the study and its results by clicking here.