- Novartis conducted a trial involving 8,442 patients in order to evaluate the effect of LCZ696 on cardiovascular outcomes. The trial was stopped early because it showed “overwhelming benefit” compared with the standard of care therapy, enalapril.
- LCZ696 reduced the risk of cardiovascular (CVD)-related death by a staggering 20% and heart failure hospitalizations by 21%. It is being reviewed by the FDA under the provisions of a fast-track designation.
- Experts predict that LCZ696 could replace a large percentage of the traditional ACE inhibitors and angiotensin receptor blockers that are currently prescribed for heart disease.
Novartis is planning to submit an application for the approval of LCZ696, an angiotensin receptor neprilysin inhibitor, to the FDA and the European Medicines Agency (EMA) in late 2014 and early 2015, respectively. Results from clinical trials showing significantly better outcomes for LCZ696-treated patients compared with placebo-treated patients were published in the New England Journal of Medicine on August 30.
In addition to significant reductions in CVD-related death and heart failure hospitalizations, LCZ696 also reduced all-cause mortality by 16%. The treatment is a twice-daily oral medication with relatively few side effects -- and chances are it will win rapid approval.
Novartis' stock was up 4.3% -- the largest gain in nearly three years -- on the trial results. "This is going to become one of our key brands," said Novartis pharmaceutical division exec David Epstein in an interview with Bloomberg. "It's clearly a multi-billion dollar opportunity." While Epstein didn't delve into specifics, other analysts have estimated that the drug could generate $8 billion in sales per year.