Drug maker Novartis released highly anticipated results from its clinical trial, PARADIGM-HF, showing its new heart failure drug cut cardiovascular deaths by 20%. The results were announced at the European Society of Cardiology meeting on Saturday.
Novartis has been testing a drug called LCZ696 for chronic heart failure in hopes of replacing ACE inhibitors, one of the mainstays of heart failure treatment. In March, an ethics council that was monitoring the trial data simultaneously requested the company end the trial since it was clear that participants using LCZ696 lived longer without being hospitalized for heart failure compared to those using the standard-care ACE inhibitor, enalapril.
Anticipation over the drug's results has been mounting since the recommended closure of the trial; results were so impressive that the treatment showed potential to become the next standard of care. The latest trial showed significantly more patients on LCZ696 were alive, and they had 21% fewer hospitalizations compared to people on enalapril. They also found that the drug doubled the effect enalapril had on all-cause mortality, which is the holy grail of trial end points.
About 20 to 26 million people live with heart failure across Europe and the U.S., and even with treatment it has a poor prognosis and costs $100 billion to treat globally. The majority of those costs come from hospitalizations.
"We thought, what if we could replace the cornerstone of heart failure treatment, ACE inhibitors," says Patrice Matchaba, development head for Novartis' critical care franchise. "That's why we designed PARADIGM and it was a bold decision to make."
LCZ696 is a pill taken twice a day and is part of a new class of drugs that blocks receptors exerting harmful effects on the heart. The treatment protects the heart by reducing muscle strain, which allows the heart muscle to recover.
Fewer patients using LCZ696 discontinued the trial for adverse events, but the group did have more hypotension and non-serious angioedema compared to patients on enalapril. They had less renal impairment, hyperkalemia and cough.
Matchaba says Novartis will be submitting to the FDA by the end of 2014 and that they've already received fast-track status. They will submit in Europe the first quarter of 2015.