FDA approves larger dulaglutide doses for type 2 diabetes
The FDA approved two additional doses of the once-weekly GLP-1 receptor agonist dulaglutide, expanding the drug’s label to include 3 mg and 4.5 mg doses, according to an industry press release.
The decision is based on data from the phase 3 AWARD-11 trial, which demonstrated that adults with poorly controlled type 2 diabetes assigned higher, investigational doses of dulaglutide (Trulicity, Eli Lilly) experienced greater improvements in glycemic response and body weight compared with those assigned the originally approved dose of 1.5 mg weekly, with no new safety signals observed.
"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," Juan Pablo Frias, MD, medical director and principal investigator for the National Research Institute, said in the release. "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 HbA1c and weight reductions for people with type 2 diabetes whose current treatment may no longer be meeting their needs."
As Healio previously reported, Frias and colleagues analyzed data from 1,842 adults with type 2 diabetes inadequately controlled with metformin therapy (mean age, 57 years; mean diabetes duration, 7.6 years; mean HbA1c, 8.6%; mean BMI, 34.2 kg/m²), randomly assigned once-weekly dulaglutide 1.5 mg (Trulicity, Eli Lilly; n = 612), dulaglutide 3 mg (n = 616) and dulaglutide 4.5 mg (n = 614) for 36 weeks. All participants initiated once-weekly dulaglutide 0.75 mg for 4 weeks, followed by a stepwise dose escalation every 4 weeks to the randomized dose of 1.5 mg, 3 mg or 4.5 mg.
Researchers defined two estimands for efficacy analyses: an efficacy estimand, defined as data on-treatment without rescue medication, and a treatment-regimen estimand, defined as all data regardless of adherence or initiation of rescue.
Using the efficacy estimand, researchers found that the 3 mg and 4.5 mg doses of dulaglutide were superior to the 1.5 mg dose for change in HbA1c from baseline. Mean reductions from baseline were 1.53% for the 1.5 mg dose, 1.71% for the 3 mg dose (P = .003) and 1.87% for the 4.5 mg dose (P < .001).
"People find the Trulicity pen simple and easy-to-use," Leonard Glass, MD, FACE, vice president of Medical Affairs, Lilly, said in the release. "Now, with the 3 [mg] and 4.5 mg doses available, people with type 2 diabetes who use Trulicity can benefit from additional HbA1c and weight loss as their condition progresses."
In February, the FDA approved dulaglutide for the reduction of major adverse cardiovascular events for adults with type 2 diabetes who have established cardiovascular disease or multiple CV risk factors, making it the first type 2 diabetes drug approved for primary and secondary prevention populations.
In the release, Lilly stated the additional doses of Trulicity will be available in United States pharmacies in late September.
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.