China’s National Medical Products Administration (NMPA) has granted approval to Forxiga (dapagliflozin) as a groundbreaking solution in the fight against heart failure (HF). This innovative medication aims to reduce the risk of cardiovascular death, hospitalization due to heart failure, and urgent heart failure visits among adults grappling with symptomatic chronic HF. What’s remarkable is that this approval extends to patients regardless of their ejection fraction phenotype, marking a pivotal advancement in patient care.
The foundation for this approval lies in the positive outcomes of the DELIVER Phase III trial. This study’s results, combined with those from the DAPA-HF Phase III trials, have not only endorsed dapagliflozin but also heralded it as the first HF medication to confer a mortality advantage across the entire spectrum of ejection fractions.
“This broader indication for Forxiga in adults with symptomatic chronic heart failure across the full ejection fraction range is a significant advancement for patients. It represents an exciting turning point in the battle against heart failure given the unmet treatment needs and the absence until now of treatments that reduce mortality in this setting. Importantly, this development underscores our commitment to accelerating earlier detection and coordinated care, to address the complexities of heart failure across the disease spectrum.”
– Ruud Dobber, Executive Vice President, and President BioPharmaceuticals Business Unit, AstraZeneca
Heart failure, a complex syndrome arising from inadequate blood circulation by the heart, affects a staggering 4.5 million individuals in China. The sobering statistic that roughly half of HF patients succumb within five years of diagnosis underscores the pressing need for effective interventions. Particularly, patients with an ejection fraction surpassing 40% are exposed to heightened risks of mortality and hospitalization, coupled with pronounced symptoms and physical limitations, leading to a compromised quality of life.
Intriguingly, the economic impact of HF in China is formidable, manifesting through substantial healthcare expenses and resource consumption. At the forefront of this burden is hospitalization, which constitutes a major share of HF treatment costs. Astonishingly, HF patients endure an average hospital stay of 30 days annually.
Notably, Forxiga’s impact isn’t confined to HF alone. It has secured approval for treating patients with type 2 diabetes (T2D), heart failure with reduced ejection fraction (HFrEF), and chronic kidney disease (CKD) across more than 100 countries. This global recognition spans regions as diverse as China, Japan, the United States, and the European Union, cementing Forxiga’s position as a transformative force in the realm of healthcare.
The NMPA’s green light for Forxiga marks a pivotal juncture in China’s battle against heart failure, offering newfound hope to millions grappling with this debilitating condition. The ripple effect of this approval extends beyond borders, showcasing how pharmaceutical innovation can rewrite the narrative for patients worldwide.
Related: Farxiga/Forxiga: Drug For Diabetes, Heart Failure And Kidney Disease
