Novartis may soon offer a new cardiac therapy drug in the market as it is set to apply approval for its experimental drug for chronic heart failure earlier than expected.
The Swiss pharmaceutical company is closing its late-stage clinical trial of the drug called LCZ696 early following positive and promising results. The drug company said that an independent committee had unanimously recommended that it end the PARADIGM-HF study, which evaluated the effects of the LCZ696 drug in patients with the condition known as heart failure with reduced ejection fraction (HF-REF).
Results of the trial showed that the patients who were treated with the experimental drug lived longer than the patients who got standard treatment.
"Novartis announced today that the Data Monitoring Committee (DMC) unanimously recommended early closure of the PARADIGM-HF study, indicating patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril," the company said in a statement.
The Paradigm-HF study involved more than 8,000 patients who randomly received either the experimental drug LCZ696 or the enalapril, the current gold standard of treatment.
Will Novartis' new drug become the next gold standard?
Milton Packer, co-principal investigator of the Paradigm-HF study, told Forbes' Larry Husten that the trial was terminated early because of the significant reduction in deaths of patients who received Novartis' drug instead of the currently accepted gold standard of care, something significant in terms of therapies for cardiovascular conditions as only a few drugs are currently able to reduce cardiovascular mortality.
Because use of the LCZ696 was also shown to have better outcomes than the current gold standard, it may even be possible that it will replace the currently known standard of therapy.
"As good as ACE inhibitors have been in heart failure perhaps there is something that is better, and better is what we need," said former president of the American Heart Association (AHA) Clyde Yancy. "We won't be able to fully arbitrate these results until they're seen, but given the increasing morbidity of heart failure, the increasing cost of care, and the increasing cost to human life, having something better than an ACE inhibitor really does qualify as a breakthrough."
