Eli Lilly's Trulicity (dulaglutide) Receives the US FDA's Approval for Additional Doses to Treat Type 2 Diabetes
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- The approval is based on P-III AWARD-11 study assessing Trulicity (3.0mg & 4.5mg- qw) vs Trulicity (1.5 mg) in 1-842 patients with T2D
- The P-III study demonstrated that additional doses led to further benefits in A1C (-17% & -19% vs -1.5%) and bodyweight reduction (-8.8 & -10.4 vs -6.8 pounds) @36wks. in people with inadequately controlled T2D on concomitant metformin therapy respectively
- The P-III study results are under EMA’s review for approval- expected this year. The additional doses of Trulicity will be available in US’ pharmacies later this month
Ref: PRNewswire | Image: Eli Lilly
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