- The American College of Cardiology, the American Heart Association and the Heart Failure Society of America have jointly issued updated practice guidelines giving Entresto a class 1 recommendation for management of heart failure with reduced ejection fraction.
- This update, which is earlier than expected, comes at a time when Novartis is dealing with Entresto's weaker-than-expected launch.
- Entresto is now recommended as an alternative treatment to ACE inhibitors or angiotensin II receptor blockers (ARBs), which are the current standard of care.
The action is like a gift for Novartis, which only recorded $17 million in earnings for the first quarter of 2016, and expects $200 million in FY earnings for 2016.
There has been a lot of speculation as to why uptake has been so slow for Entresto, but two factors clearly have emerged: Payers took several months to review Entresto (which has a list price of $4,600 per year) and treating cardiologists tend to stick with the tried and true.
However, the strength of the evidence base for Entresto is strong. In a phase 3 pivotal trial, Entresto reduced the rate of hospitalization by 20% compared with enalapril in HF patients with reduced ejection fraction, and all-cause mortality was reduced by 16%.
And to add to that clinical prowess, Novartis is launching an even more ambitious trial. The FortiHFy clinical program is comprised of 40 clinical trials and is enrolling patients in more than 50 countries. Joe Jimenez, CEO of Novartis, continues to be confident that Entresto will eventually be a $5 billion per year drug.