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06-30-2021 | Dapagliflozin | News

Dapagliflozin gains positive CHMP opinion for CKD indication

Author: Eleanor McDermid


medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication for dapagliflozin to cover chronic kidney disease (CKD).

This follows the FDA approval, based on the positive outcomes of the DAPA-CKD trial, in which all participants had CKD, but only around two-thirds had diabetes.

In the EU, dapagliflozin is already approved for glucose-lowering in people with type 2 diabetes, as an adjunct to insulin for glucose-lowering treatment in people with type 1 diabetes and a BMI of at least 27 kg/m2, and for chronic heart failure with reduced ejection fraction.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group


Novel clinical evidence in continuous glucose monitoring

Novel clinical evidence in continuous glucose monitoring

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Jean-Pierre Riveline uses data from real-life continuous glucose monitoring studies to illustrate how these can uncover critical information about clinical outcomes that are hard to assess in randomized controlled trials.

This video has been developed through unrestricted educational funding from Abbott Diabetes Care.

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