Sacubitril/valsartan receives expanded indication, including for some with HFpEF
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Novartis announced the FDA has granted an expanded indication for sacubitril/valsartan to lower risk for CV death and HF hospitalization in adult patients with chronic HF.
The indication covers certain patients with HF with preserved ejection fraction but does not specify a cutoff left ventricular EF.
According to a press release from the company, the benefits of sacubitril/valsartan (Entresto, Novartis) are greatest among patients with HF and LVEF below normal.
The new indication was based in data from the PARAGON-HF trial.
As Healio previously reported, in PARAGON-HF, sacubitril/valsartan was not superior to valsartan for the reduction of CV death and HF hospitalization events among patients with LVEF at least 45%; however, certain groups did experience a benefit, including women and patients with EF equal to or below the median of 57%.
The company stated in the release that the new indication makes sacubitril/valsartan the first medication to be approved for use both in patients with HF with reduced ejection fraction and in certain patients with HFpEF.
According to the release, the new label will mention that LVEF is a variable measure and that clinical judgment is necessary to determine whether a patient should be prescribed the drug.
“This approval is a significant advancement, providing a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region we normally considered reduced. Until now, treatment for these patients was largely empiric,” Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women's Hospital and co-chair of the PARAGON-HF executive committee, said in the release. “We can now offer a treatment to a wider range of patients who have an LVEF below normal.”
Perspective
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Mary Norine Walsh, MD, MACC
I was pleased to see the FDA approval of the expanded indication for sacubitril/valsartan because this now will allow for treatment of a patient group that has previously been underserved. The PARAGON-HF trial showed benefits for patients with LVEF that is below normal, including those with only mild decrease in LV function. We have previously not had robust data to guide our treatment of these patients. Importantly, over half of the patients enrolled in the trial were women. This is unusual for a trial of HF therapies and we can be assured that our women patients benefit from this therapy.
The data are sound and what remains to be determined is how we should best treat our patients with normal LV function. We still have very limited strategies for these patients.
With its approval, the FDA said that ‘clinical judgement should be used in deciding whom to treat.’ It remains to be seen how the insurance payers will accept this broadened indication and accept a clinician’s judgement as to the benefit for a given patient. Many patients have little coverage and very high co-pays and if the payers take a restrictive view, our hands will be tied in providing the medication to the expanded population that has been shown to benefit.
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