March 31st, 2014
Early Success for Novel Novartis Heart Failure Drug
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF trial because the trial had demonstrated a significant reduction in the combined primary endpoint of cardiovascular death and heart failure hospitalization.
PARADIGM-HF randomized patients with heart failure and reduced left ventricular ejection fraction to either the ACE inhibitor enalapril or LCZ696, an Angiotensin Receptor Neprilysin Inhibitor (ARNI) that is the first in its class. Almost 8,500 patients were studied in the trial, which Novartis said made it the largest-ever trial in heart failure.
“The results of PARADIGM-HF are truly impressive” said heart failure expert Milton Packer, a Principal Investigator of the trial. “The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure.”
Novartis said the trial findings will be presented at a medical conference in the future and that the company will seek to gain approval for the drug with regulators.
The announcement follows by only a few days the rejection of a different Novartis heart failure compound, serelaxin, by an FDA advisory panel.