Novartis New Heart Failure Drug Shows Promising Results in Trial Study

Last week two FDA panels unanimously voted against the approval of a new Novartis heart failure drug called serelaxin. Today, Novartis has ended a late-stage clinical trial of another heart failure drug called LCZ696 because of its strong results.

The Swiss-based drug manufacturer has recently sought to develop a heart failure drug that reduces the diseases morbidity and mortality rate because they face competition with their top-selling blood pressure drug, Diovan. Serelaxin was ruled to have provided insufficient evidence on the drug's overall effect on patients with heart failure. But now with LCZ696's trial results, Serelaxin may not have to be rushed for approval from the FDA and European Union.

If approved, LCZ696 could be the first drug therapy provided to reduce the morbidity and mortality in patients with heart failure with preserved ejection fraction (HF-PEF). Approximately a combined 20 million Americans and Europeans suffer from this specific form of heart failure, which will provide the new drug with an ample market for sale. In the United States, about half of patients diagnosed with heart failure die within five years and the disease amasses $32 billion in healthcare costs per year. Europe's numbers are likely higher.

Phase II of the drug's trial study showed a reduction in the morbidity and mortality rate for patients with HR-PEF, Novartis reported back in August of 2012. After 12 weeks, the drug reduced a marker of stress on the heart known as NT-proBNP, which is present in patients with heart failure.

"These Phase II results show that this novel treatment approach has the potential to reduce stress to the heart and to reduce enlargement of the left atrium of the heart, which occurs in patients with heart failure," said Dr. Scott Solomon, Professor of Medicine at Harvard University, in this Novartis news release.

Phase III of LCZ696 clinical trial study showed strong results in treating patients with heart failure with reduced ejection fraction (HF-REF). Novartis ended the study early and is looking to present the data and results to global regulators in order to get the drug approved as quickly as possible. LCZ696 has the potential of raking in $5 billion worth of annual sales if approved and could be the first drug approved to treat chronic heart failure in over a decade.

To read more about Novartis and their LCZ696 heart failure drug, visit this Reuters news article.