FDA approves first major new heart failure drug in a decade
- On Wednesday, the FDA approved Amgen's Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.
- Corlanor is approved for use in patients who have chronic heart failure caused by the lower-left part of their heart not contracting properly. This approval, alongside the eventual expected approval of the company's PCSK9 inhibiting cholesterol drug, will add some major oomph to Amgen's pipeline.
- To use this drug, patients should have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute, and they should also be taking the highest dose of beta-blockers they can tolerate, per the FDA.
The 5.1 million people in the U.S. who are affected by heart failure, in which the heart can't pump enough blood to meet the body's needs, have traditionally been treated with various ACE inhibitors, ARBs, beta-blockers, diuretics, blood vessel dilators, or digoxin. Corlanor represents a new therapeutic class for the treatment of heart failure, as well as the first new medication for the treatment of heart failure in the last 10 years.
According to a fact sheet from Amgen, Corlanor reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current ("funny" current) to slow the heart rate with no effect on ventricular repolarization and no effects on myocardial contractility.
This oral medication has been tested extensively in 6,505 participants and has been found to be both effective and safe. In addition, patients who take the drug will receive a Patient Medication Guide that provides instructions for use.
There's another major heart failure drug whose approval may be on the horizon—Novartis' investigational LCZ696, which could become a major blockbuster. That drug was granted FDA priority review in February.