Second Novartis heart failure drug looks like a winner
Just days after suffering a resounding rejection of its first heart failure candidate, Novartis looks to have come up trumps with its second.
Last week saw an FDA committee recommend against the approval of serelaxin because of unconvincing efficacy data, but now a second candidate, LCZ696, has produced dramatic results in cutting hospitalisation and deaths in heart failure patients.
The twice a day pill for heart failure now looks likely to overtake its stablemate, even though serelaxin has been designated a 'Breakthrough Therapy' and LCZ696 has not.
The news is an exciting development for patients with heart failure, which is an area of great unmet medical need. Analysts say this could translate into a blockbuster opportunity for Novartis.
An investor note from Citi analyst Andrew Baum said the drug could exceed $5 billion in peak annual sales if approved, with more than 20 million people currently suffering from heart failure across the US and Europe.
Trial stopped early
The results from the trial were so good the Data Monitoring Committee (DMC) unanimously recommended that it be stopped early, after confirming the drug hit its combined primary endpoint of reducing cardiovascular death and cutting heart failure hospitalisations versus the ACE inhibitor enalapril.
"The results of PARADIGM-HF are truly impressive" said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA and one of the two Principal Investigators. "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."
LCZ696 is a first in class medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects, while simultaneously promoting protective mechanisms. Known as an ARNI (Angiotensin Receptor Neprilysin Inhibitor) LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover.
Novartis says results of the PARADIGM-HF trial will be submitted to a major medical conference for presentation and that it will now initiate discussions with global health authorities regarding approval for marketing.
Resounding rejection for Novartis' heart failure drug