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AZ closes in Forxiga kidney disease label in EU after nod from CHMP

June 28, 2021


Forxiga (dapagliflozin) has been recommended for approval to reduce the risk of kidney damage, end-stage kidney disease, cardiovascular, death and hospitalisation for heart failure in adults with CKD who are at risk of progression by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

If the EMA follows its committee’s advice and approves the new indication, Farxiga will become the first drug in the SGLT2 inhibitor class to be available for use in the approximately 47 million people with CKD in Europe. The US FDA approved the same indication a few weeks ago.

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