China’s NMPA expands AstraZeneca’s Forxiga use as heart failure treatment

China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) for diminishing the risk of cardiovascular fatalities and hospitalizations in adults diagnosed with symptomatic chronic heart failure (HF). This follows an earlier authorization for patients suffering from heart failure with reduced ejection fraction (HFrEF). Now, Forxiga’s capabilities extend to all adults with symptomatic chronic HF, regardless of their ejection fraction phenotype.

Central to this landmark decision were the impressive outcomes from the DELIVER Phase III trial, coupled with a predetermined pooled analysis of both DELIVER and DAPA-HF Phase III studies. Notably, dapagliflozin shines as the pioneering HF drug showcasing a mortality advantage across the entire ejection fraction spectrum.

Ruud Dobber, AstraZeneca Executive Vice President and President BioPharmaceuticals Business Unit, articulated the immense value of this extended indication, stating, “This broadened application is a revolutionary stride for adult patients with symptomatic chronic heart failure across the entire ejection fraction range. The fact that treatments reducing mortality in this scope were previously non-existent makes Forxiga’s approval all the more monumental. This echoes AstraZeneca’s devotion to facilitating earlier detection and streamlined care to tackle heart failure’s multifaceted challenges.”

Heart failure is a complicated condition characterized by the heart’s inability to efficiently circulate blood. A staggering 4.5 million individuals in China grapple with this ailment, and tragically, around half succumb to it within five years post-diagnosis. Those with an ejection fraction surpassing 40% face amplified risks and suffer from pronounced symptoms, leading to significant physical constraints and deteriorated life quality. The economic ramifications in China are profound, with hospital stays, averaging 30 days per year, forming the crux of the financial burden.

Beyond China, Forxiga is sanctioned for treating patients with T2D, HFrEF, and CKD across over 100 nations, including prominent markets like the US, the EU, and Japan. It operates as a selective inhibitor of the human sodium-glucose co-transporter 2 (SGLT2), proving to be an instrumental oral treatment for patients grappling with symptomatic chronic heart failure and other conditions, such as CKD and type 2 diabetes, when used in conjunction with dietary and exercise regimens.