FDA expands dapagliflozin indication to include all patients with HF
Key takeaways:
- The FDA expanded the indication for dapagliflozin to reduce CV death risk for all patients with heart failure.
- Data from the DELIVER trial demonstrated efficacy across the full range of ejection fraction.
The FDA expanded an indication for the SGLT2 inhibitor dapagliflozin to reduce risk for CV death, HF hospitalization and urgent HF visits for adults with HF across the full range of ejection fraction, according to an industry press release.
Dapagliflozin (Farxiga, AstraZeneca) was previously approved in the U.S. for adults with HF with reduced EF.
“Approximately half of heart failure patients die within 5 years of diagnosis, highlighting an urgent unmet need for well-tolerated treatment options that can bring lifesaving benefits and reduce the risk of cardiovascular death,” Ruud Dobber, executive vice president of the biopharmaceuticals business unit at AstraZeneca, said in a press release from AstraZeneca. “The approval of Farxiga in the U.S. 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.”
As Healio previously reported, the DELIVER trial demonstrated that in adults with HF with mildly reduced or preserved EF, dapagliflozin significantly reduced risk for CV death and worsening HF compared with placebo, with no attenuation of treatment benefit for patients with the highest EF. Participants who received dapagliflozin also experienced fewer total HF hospitalizations and a marked improvement in symptom burden compared with those assigned placebo.
In an analysis of pooled data from both DELIVER and the DAPA-HF trial of patients with HFrEF, published in Nature Medicine, researchers similarly found that dapagliflozin reduced risk for every assessed outcome, including CV death, all-cause death and total HF hospitalizations, in patients with HF regardless of EF.
Dapagliflozin is approved for the treatment of adults with type 2 diabetes, HFrEF and chronic kidney disease in more than 100 countries. It recently received regulatory approvals in the European Union, United Kingdom, Japan and Turkey to extend the HF indication to include patients across the full LVEF range.
Reference:
- Jhund PS, et a. Nat Med. 2022;doi:10.1038/s41591-022-01971-4.
- Solomon SD, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2206286.
Perspective
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SGLT2 inhibitors are the only class of HF medications with proven clinical benefits in patients across the entire spectrum of ejection fraction. SGLT2 inhibitors are among the four foundational guideline-directed medical therapies for HFrEF, yet for HF with mildly reduced and preserved EF, SGLT2 inhibitors represent the only class of HF medication that can now be considered foundational. The clinical benefits with SGLT2 inhibitors accrue rapidly with reductions in HF hospitalizations and CV events within days to weeks of initiation and also early improvements in health status. These agents have a strong safety and tolerability profile, have minimal to no effects on BP and no excess risk for adverse kidney events.
The expanded labeled indication for dapagliflozin, which was approved based on the DELIVER trial, represents an important step in facilitating clinical use of this therapy for eligible patients across the entire EF spectrum. There are an estimated 2.6 million individuals in the U.S. with HF with mildly reduced or preserved EF that are eligible under this new label indication. Optimal implementation of SGLT2 inhibitors to eligible patients with HF across the EF spectrum would be projected to prevent 630,000 worsening HF events or CV deaths, with a low adverse event rate. Every effort should be made to overcome potential barriers and effectively implement this foundational therapy to all eligible HF patients, without delay.
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