AstraZeneca has announced that its drug, Forxiga (dapagliflozin), has received approval from the Chinese National Medical Products Administration (NMPA) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) and reduced ejection fraction (HFrEF). This marks a significant step forward in the treatment options available for heart failure patients in China, expanding Forxiga’s global reach.

Clinical Trial Success:

The approval was primarily driven by the positive outcomes from the phase 3 DAPA-HF clinical trial, which demonstrated that Forxiga, when used in conjunction with standard heart failure care (including an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker), significantly reduced the risk of cardiovascular death or worsening heart failure events by 26% compared to placebo. The trial included patients both with and without type-2 diabetes, showcasing Forxiga’s broad applicability in managing heart failure.

Details of Forxiga’s Mechanism and Global Approvals:

Forxiga belongs to a class of drugs known as sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors), which have been gaining recognition for their benefits in heart failure management. Apart from China, Forxiga is also approved in the United States (where it is branded as Farxiga), Europe, Japan, and several other countries for the treatment of adults with HFrEF.

Statements from AstraZeneca Executives:

Mene Pangalos, Executive Vice President of AstraZeneca BioPharmaceuticals R&D, commented on the approval, stating, “There is no known cure for chronic heart failure except for heart transplantation, which is why there is an urgent need for new treatment options that can improve symptoms and help patients live longer. This approval marks another important step forward in our ambition to improve outcomes for millions of people worldwide living with this life-threatening disease.”

The approval of Forxiga in China represents a major advancement in heart failure treatment, offering a new therapeutic option that can significantly improve patient outcomes. By reducing the risk of cardiovascular death and hospitalization, Forxiga addresses critical needs within the heart failure patient community, providing hope for improved disease management and quality of life.

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