Novartis, a global pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its new heart failure drug, called Entresto XR. This approval expands the use of the company's existing heart failure drug, Entresto, by making it available in an extended-release form.

Heart failure is a chronic condition in which the heart is unable to pump enough blood to meet the body's needs. It affects millions of people worldwide and is a leading cause of hospitalization and death. Entresto XR is a once-daily tablet that combines two medications, sacubitril and valsartan, to reduce the strain on the heart and improve its ability to pump blood.

The FDA's approval of Entresto XR was based on the results of a clinical trial that involved over 5,000 patients with heart failure. The trial showed that Entresto XR was superior to the standard of care, enalapril, in reducing the risk of cardiovascular death or hospitalization for heart failure. In addition, Entresto XR was found to be well-tolerated by patients, with a safety profile similar to that of the original Entresto formulation.

"We are thrilled to receive FDA approval for Entresto XR, which represents an important advance in the treatment of heart failure," said John Tsai, head of global drug development and chief medical officer at Novartis. "The clinical trial results demonstrate that Entresto XR can significantly reduce the risk of cardiovascular death or hospitalization for heart failure, and we believe that this extended-release formulation will provide added convenience for patients and physicians."

The approval of Entresto XR is expected to have a significant impact on the treatment of heart failure, as it provides patients with a new once-daily option that has been shown to be more effective than current standard of care treatments. In addition, the extended-release formulation may provide added convenience for patients, who will only need to take the medication once a day.

"Entresto XR has the potential to transform the way we treat heart failure," said Clyde Yancy, MD, chief of cardiology at Northwestern University Feinberg School of Medicine. "The clinical trial results are impressive, and the extended-release formulation should make it easier for patients to take their medication as prescribed. This is a major step forward in improving outcomes for patients with heart failure."

In conclusion, the FDA's approval of Entresto XR represents an important advance in the treatment of heart failure. This new extended-release formulation of the existing Entresto drug provides patients with a once-daily option that has been shown to be more effective than current standard of care treatments. This is a significant development in the fight against heart failure, which affects millions of people worldwide.

https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-heart-failure-drug.