AstraZeneca’s Farxiga (dapagliflozin) oral SGLT2 inhibitor just landed FDA approval for a far wider range of heart failure patients, now covering risk reduction of cardiovascular death, heart failure hospitalization, and urgent heart failure ED visits among all adults with HF — regardless of their left ventricular ejection fraction status.
That’s a notable extension from Farxiga’s previous approval for patients with HFrEF, and should add even more HF momentum for SGLT2 inhibitors.
This is the latest in a series of Farxiga’s FDA extensions, which gained its initial approval for type 2 diabetes patients in 2014, and has since added FDA approvals for preventing HF in type 2 diabetes patients (2019), reducing the risk of CV death and hospitalization in HFrEF patients regardless of diabetes status (2020), and risk reduction in patients with CKD (2021).
Farxiga’s FDA extension stands on the shoulders of two key 2022 studies.
- The phase III DELIVER Trial showed that Farxiga significantly reduced CV death or worsening HF in patients with HFmrEF or HFpEF.
- Pooled analysis of the DAPA-HF and DELIVER Phase III trials showed that Farxiga reduced composite risks (CV death, HF hospitalization, urgent heart failure) in patients across the LVEF range.
Those results (which include many HF “firsts” for SGLT2s) and Farxiga’s newly-expanded HF approvals could position AstraZeneca as a HF treatment leader, although Farxiga has some catching up to do with Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin), which gained similar “all HF” approval in early 2022.
In reality, both SGLT2s are likely on track for huge years, noting that Farxiga’s previous indications drove $4.3B in 2022 revenue (+46% YoY), while and Boehringer Ingelheim’s Jardiance 2022 revenue soared to $6.35B (+48% YoY) following its own HF extensions.
America’s 7 million heart failure patients have historically had to live with the fact that nearly half of them would die within five years of diagnosis, but the recent surge of SGLT2 inhibitor treatments and approvals seems to be changing the HF paradigm. That shift is big news for AstraZeneca and its peers in the “all HF patients” SGLT2 club, and should drive big changes in how we detect and care for HF patients – especially if payors’ SGLT2 coverage also changes.