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Novartis set to close heart drug study early after strong results
March 31, 2014 / 6:52 AM / 4 years ago

Novartis set to close heart drug study early after strong results

ZURICH, March 31 (Reuters) - Swiss drugmaker Novartis is set to end a late-stage clinical trial of a chronic heart failure drug early, following strong interim results.

The Basel-based firm said on Monday an independent committee had unanimously recommended it close its PARADIGM-HF study ahead of time after results showed patients receiving its LCZ696 drug lived longer without being hospitalised for heart failure than those who were given the standard care.

The study was evaluating LCZ696 in patients with so-called reduced ejection fraction chronic heart failure.

Heart failure is a condition where the heart struggles to pump blood around the body. Unlike a heart attack, in which a heart artery becomes blocked, it develops progressively.

Novartis said it would start talks with global health regulators about filing for drug for approval.

The Swiss firm, long a major player in cardiovascular medicine, is looking to LCZ696 as one of two new treatments for heart failure that could revive its fortunes at a time when top-selling blood pressure pill Diovan is facing generic competition.

Its other acute heart failure drug Serelaxin received a setback last week when a panel of advisers to the U.S. Food and Drug Administration recommended the drug not be approved because of insufficient evidence it improves symptoms.

The panel’s recommendation echoed that of European regulators which also ruled against the drug. (Reporting by Caroline Copley; Editing by Mark Potter)

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