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The approval was based on data from the PARAGON-HF study.
The United States Food and Drug Administration (FDA) has expanded the label of sacubitril / valsartan (Entresto), a therapy to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure chronic.
The approval, granted to Novartis, is based on clinical data showing clear benefits for patients with lower than normal left ventricular ejection fraction (LVEF). The label also states that LVEF is a variable measure and that clinical judgment should be used in deciding who to treat.
The treatment
The treatment represents the first drug of benefit for patients diagnosed with guideline-defined heart failure, which includes both those with heart failure with reduced ejection fraction (HFrEF) and many patients with heart failure. with preserved ejection fraction (HFpEF).
“This approval is a significant breakthrough, providing treatment for many patients who were not previously eligible for treatment because their ejection fraction was greater than the region we would normally consider reduced. Until now, the treatment of these patients has been largely empirical, ”said 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, in a statement. “We can now offer treatment to a wider range of patients with lower than normal LVEF.”
The trial
The FDA’s decision is based on data from the PARAGON-HF study, the largest and only active-controlled Phase 3 study in patients with HFpEF defined by the guidelines. In the study, the researchers found the greatest benefit in patients whose LVEF was below normal.
There are currently approximately 6 million people in the United States with chronic heart failure, including 3 million with HFrEF and 2 million with HFpEF with LVEF below normal.
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