AstraZeneca’s blockbuster drug Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent heart failure.
The Food and Drug Administration (FDA) approval was based on results from a Phase III trial. Farxiga was previously approved in the US for some adults with a type of HF.
Ruud Dobber, executive vice president of BioPharmaceuticals Business Unit at AstraZeneca, said: “Approximately half of heart failure patients die within five years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring life-saving benefits and reduce the risk of cardiovascular death. The approval of Farxiga in the US not only reinforces AstraZeneca’s commitment to reducing the burden of this complex and life-threatening disease but will help patients across the full spectrum of heart failure lead healthier lives.”
HF is a chronic, long-term condition that worsens over time and affects almost seven million people in the US. It is also the leading cause of hospitalization for those over 65 years and represents a significant clinical and economic burden.
Farxiga is approved for treating patients with type-2 diabetes, HFrEF, and chronic kidney disease in more than 100 countries worldwide including the US, the European Union China, and Japan.
HF is a chronic, long-term condition that worsens over time and affects nearly 64 million people worldwide.
Farxiga accounts for $4 billion in annual sales for AstraZeneca. The cost of 30 pills taken daily runs about $550 a month for those without insurance coverage. Discounts are available from AstraZeneca for those who cannot afford that cost.
AstraZeneca employs about 1,500 in administrative, logistics, and manufacturing positions in northern Delaware.