An investigational new heart failure drug could be poised to change the face of cardiology based on Hot Line results presented today at ESC Congress 2014.
Findings from the PARADIGM-HF trial, published simultaneously in the New England Journal of Medicine, “are extraordinarily powerful and compelling; they are destined to change the management of patients with chronic heart failure for years to come,” said Milton Packer, MD, co-primary author of the study from University of Texas Southwestern Medical Center, in Dallas, Texas USA.
“This really is an astonishing result and a real breakthrough for patients with heart failure,” added John McMurray, MD, the other co-primary author, from the University of Glasgow, UK.
The new agent, an angiotensin receptor-neprilysin inhibitor (ARNI) known as LCZ696, has already been granted Fast Track status by the United States Food and Drug Administration (FDA) – a designation which can expedite the review of new medicines intended to treat serious or life-threatening conditions. Fast Track designation also allows for rolling submission in the US, which Novartis said it expects to complete by the end of 2014. The company said it aims to file in Europe in early 2015.
“To say that we are excited is an understatement. We are absolutely thrilled,” said Dr. Packer.
“Given the survival advantage of LCZ696 over currently available drugs, once this drug becomes available, it would be difficult to understand why physicians would continue to use traditional angiotensin converting-enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for the treatment of heart failure.”