Novartis Ends Heart Failure Drug Tests Early on Strong Results
Swiss drug maker Novartis has ended a late-stage clinical trial of a chronic heart failure drug early, following strong interim results.
The company said an independent committee had unanimously recommended it close its Paradigm-HF trials for treatment of reduced ejection fraction chronic heart failure ahead of time after test results showed patients receiving its LCZ696 drug lived longer without being hospitalized for heart failure than those who were given the standard care.
It now plans to start talks with global health regulators about filing the drug for approval.
Novartis is looking to LCZ696, a combination of top-selling blood pressure pill Diovan (valsartan) and a neprilysin inhibitor, as one of two new treatments for heart failure to succeed Diovan, which is facing generic competition.
Analysts told the news agency Reuters that the drug could have the potential to achieve peak annual sales of more than $5 billion and could become the first new medicine to be approved for chronic heart failure in over a decade.
The positive news for LCZ696 contrasts with recent setbacks for Novartis' other acute heart failure drug, Serelaxin.
In late March, a panel of advisers to the U.S. Food and Drug Administration recommended that Serelaxin should not be approved because of insufficient evidence it improves symptoms. This followed a thumbs-down by European regulators.
