The U.S. Food and Drug Administration (FDA) has approved AstraZeneca's Farxiga (dapagliflozin) for a new indication: reducing the risk of cardiovascular death and hospitalization for heart failure in adults with reduced ejection fraction (HFrEF), regardless of whether they have type 2 diabetes. This approval marks a significant advancement in heart failure treatment, offering a new option for a broad range of patients suffering from this condition.
Clinical Trial Data
The approval was based on the positive results from the Phase 3 DAPA-HF trial. The trial demonstrated that Farxiga, when added to standard of care, resulted in a statistically significant and clinically meaningful reduction of 26% in the composite outcome of cardiovascular (CV) death or worsening of heart failure compared to placebo (p<0.001). The study also indicated that for every 21 patients treated with Farxiga, one CV death, hospitalization for heart failure, or urgent visit associated with heart failure could be avoided during the trial duration.
Impact on Heart Failure Treatment
Farxiga is now the first SGLT2 inhibitor approved by the FDA to treat patients with HFrEF, irrespective of their diabetes status. This broadens the treatment landscape for heart failure, as previous SGLT2 inhibitor approvals were often limited to patients with both type 2 diabetes and cardiovascular disease or risk factors. Heart failure affects millions of people worldwide, and approximately half of them have HFrEF. This condition impairs the heart's ability to effectively pump blood, leading to symptoms such as fatigue, shortness of breath, and fluid retention.
AstraZeneca's Expanding Portfolio
AstraZeneca has been strategically building its cardiovascular and metabolic franchise around Farxiga. Originally approved for type 2 diabetes, Farxiga became a key asset in AstraZeneca's portfolio after the company acquired Bristol-Myers Squibb's share of their diabetes joint venture in 2013. In the first quarter of this year, Farxiga generated $407 million in revenue, representing a 16% increase.
Competitive Landscape
While other companies like Eli Lilly and Boehringer Ingelheim are also developing SGLT2 inhibitors for heart failure, AstraZeneca's Farxiga has gained a competitive edge with this latest approval. The FDA had previously granted Farxiga a priority review, expediting the approval process. The FDA is also reviewing data from the DAPA-CKD trial, which investigated Farxiga's efficacy in chronic kidney disease and was halted early due to positive results.
Future Considerations
Despite its success, Farxiga faces potential generic competition in the U.S. The FDA has tentatively approved a generic version, but its launch is contingent upon the resolution of an ongoing patent dispute.
