The FDA approval, which enables to expand the label of once-weekly Trulicity to include 3.0mg and 4.5mg doses, was based on data from the AWARD-11 phase 3 trial, said Eli Lilly.
Trulicity, a prescription medicine for adults with type 2 diabetes, will help enhance blood sugar and minimise the risk of major cardiovascular events such as death, heart attack, or stroke in people with heart disease or multiple cardiovascular risk factors.
By using two different statistical approaches, the AWARD-11 trial assessed the safety and efficacy of additional doses of Trulicity compared to Trulicity 1.5mg.
Eli Lilly recruited 1,842 participants with type 2 diabetes in the randomised, double-blind and parallel arm study.
According to the company, the trial’s primary objective was to show that a once-weekly investigational dulaglutide dose was superior to the approved Trulicity 1.5mg dose at 36 weeks in people with inadequately controlled type 2 diabetes on concomitant metformin therapy.
If one or both doses achieved statistical significance for the endpoints, the primary and secondary objectives could be reached in the trial.
The trial’s secondary and exploratory outcomes comprise change from baseline in mean body weight and fasting serum glucose (FSG), percentage of patients reaching an A1C goal of less than 7% and occurrence of hypoglycemic episodes and pharmacokinetics at steady-state through 36 and 52 weeks.
Eli Lilly will start selling the additional doses of Trulicity in the US pharmacies by the end of this month.
The AWARD-11 results are also under assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Based on the agency’s opinion, the approval for additional doses of Trulicity from the European Commission is expected by the end of this year.
Eli Lilly medical affairs vice president Dr Leonard Glass said: “People find the Trulicity pen simple and easy-to-use.
“Now, with the 3.0 and 4.5 doses available, people with type 2 diabetes who use Trulicity can benefit from additional A1C and weight loss as their condition progresses.”
In June this year, Eli Lilly commenced a phase 3 clinical trial with baricitinib, marketed as Olumiant, for hospitalised Covid-19 patients.