The US FDA has approved Brenzavvy, an oral sodium-glucose cotransporter 2 inhibitor that is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D
The approval was based on the results from a clinical program in 23 clinical trials evaluating the safety & efficacy of Brenzavvy in 5000+ adult patients with T2D mellitus. The P-III studies showed a reduction in hemoglobin A1c & fasting blood sugar after 24wks. as monotx & in combination with metformin, or as an add-on to SoC treatment
Brenzavvy will be available as 20mg oral tablets to be taken qd. The one P-II trial results showed that the therapy was well-tolerated & provide a durable & clinical improvement in glycemic control over 96wks.
Ref: Businesswire | Image: TheracosBio
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