Novartis set to redraw the heart failure map with rapid approval of game-changer Entresto
- The FDA on Tuesday approved Novartis' heart failure drug Entresto (formerly known under the code name LCZ696). The therapy is expected to be one of Novartis' biggest launches ever and is one of the most highly-anticipated drugs of the year.
- Novartis is reportedly pricing the medication at about $12.50 per day, or just under $4,600 per year.
- Heart failure affects about 5.1 million Americans, and Novartis has estimated that more than two million Americans could be eligible to take Entresto. In a large clinical trial, Novartis took the gutsy step of comparing Entresto head-to-head against the current standard of care for heart failure, enalapril—with strikingly impressive results, lowering CVD-related hospitalizations and deaths by 20%.
With this approval, Novartis has set the stage for what may be one of the most important pharmaceutical advances of the 21st century.
Heart failure is a notoriously difficult therapeutic category to tackle, and it's not every day that a potentially paradigm-shifting drug for the condition comes around. That's what makes Entresto so exciting. Not only did the oral therapy significantly lower CVD-related hospitalization and death risk in clinical trials—it also reduced all-cause mortality by 16%.
So it's not too surprising that Novartis has particularly lofty expectations for Entresto sales. Back when the late-stage trial results were first released, David Epstein, a pharma division exec at the company, told Bloomberg that the drug was a multi-billion dollar opportunity. Other analysts have ventured into more detail and predicted that, eventually, the drug could bring in a staggering $8 billion per year in sales.
The question is: Will Novartis face the same sort of payer pushback on pricing, despite the relatively reasonable rates that it has set, as companies like Gilead and cancer immunotherapy developers have had to endure?