Important unknowns about Novartis's potential paradigm shifter LCZ696
This article was originally published in Scrip
Despite the $8.3bn boost to Novartis's stock market capitalization yesterday on the positive trial news for the novel drug LCZ696 in chronic heart failure, consequential details remain unknown.
Novartis's share price rose 4.2% to $85.02 on the New York Stock Exchange on 31 March after the Swiss firm announced the early closure of its PARADIGM-HF trial of LCZ696 in chronic heart failure because of the strong evidence of efficacy (scripintelligence.com, 31 March 2014).
Analysts suggested that the product could replace ACE inhibitors as the standard of care to treat patients with heart failure with reduced ejection fraction, and that more than 2 million patients may be eligible for treatment with the drug in the US. However, the devil may be in the detail.
"These are of course very encouraging top-line results. From the release, it sounds as if patients had both reduced CV death and heart failure hospitalizations," commented Dr Peter Chang, a BioMedTracker analyst with Sagient Research. "It will be important to see details, such as whether there are subgroups of patients the drug worked particularly well in and all-cause mortality. Usage will also depend on the magnitude of the benefit, and it will be important to see that there was not just a short delay in the time to events. Per the trial design paper, it was powered to show a 15% risk reduction."
BioMedTracker conducted a pulse survey of 10 US cardiologists based on the results, and the percent of HFrEF patients (heart failure with reduced ejection fraction) in whom the cardiologists would use LCZ696 varied from 21% if it reduced both CV death and hospitalizations by 15%, to 57% if it reduced both by 50%. (To see the full survey results for the distribution of how physicians would prescribe the drug for both existing and new patients, click here [nb free registration required].)