(RTTNews) - British drug major AstraZeneca Plc. (AZN.L, AZN) announced Wednesday that China's National Medical Products Administration or NMPA has approved Forxiga's (dapagliflozin) cardiovascular outcomes benefit.
NMPA has updated the label for Forxiga to include data from the DECLARE-TIMI 58 Phase III trial that reduced the risk of composite of hospitalisation for heart failure or cardiovascular death in type-2 diabetes.
The trial confirmed the well-established safety profile of Forxiga, which is known as Farxiga in the US. It is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with T2D.
DECLARE-TIMI 58 is the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CV outcomes trial conducted to date. The data from the trial were published in The New England Journal of Medicine in January 2019.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said, "The DECLARE-TIMI 58 Phase III data show that Forxiga reduces the risk of hospitalisation for heart failure and, with this label update, we look forward to bringing this significant benefit to patients in China."
The NMPA label update, based on the DECLARE-TIMI 58 Phase III data, follows the update to the EU marketing authorisation in August 2019 and the approval by the US Food and Drug Administration in October 2019 of an indication for Forxiga to reduce the risk of hHF in adults with T2D and established CV disease or multiple CV risk factors.
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