Cardiology Pharmaceuticals

AstraZeneca’s Farxiga Lands Heart Failure FDA Extension

Box of Farxiga

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.

The Takeaway

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.

Get twice-weekly insights on the biggest stories shaping cardiology.

You might also like

Surgeries & Interventions June 23, 2025

Edwards’ Evoque Might Have More Adverse Events Than Previously Known June 23, 2025

Over a year after becoming the first FDA-approved transcatheter tricuspid valve replacement system, a new JACC study suggests Edwards Lifesciences’ Evoque TTVR system might have some risks that regulators hadn’t previously considered. Searching for more answers about Evoque’s real world risks, researchers pulled data from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database […]

Cardiology Business June 19, 2025

Lilly Buys Verve, Bringing Gene Editing Mainstream June 19, 2025

Gene editing for heart disease just got a major boost as Eli Lilly acquired Verve Therapeutics and its one-dose cholesterol drugs for up to $1.3B, marking a new path for Verve’s therapies to go mainstream. Part of the acquisition likely stems from Verve’s recent impressive trial results for its PCSK9-blocking treatment, VERVE-102, which lowered LDL-C […]

Cardiac Imaging June 19, 2025

New AI-driven Tool Aids in Mitral Valve Assessment June 19, 2025

By: Jimmy Su, Ph.D. Principal Scientist, Cardiovascular Ultrasound, Philips A new tool, Automated 3D Color Flow Quantification (3D Auto CFQ), removes the reliance on assumptions when quantifying mitral regurgitation and replaces it with a reliable and robust, AI-driven method that delivers precise measurement of mitral valve regurgitant volume (RVol) regardless of orifice shape and size. Eliminating assumptions: Quantification […]

You might also like..

Select All

You're signed up!

It's great to have you as a reader. Check your inbox for a welcome email.

-- The Cardiac Wire Team

You're all set!