Corlanor, also known by its generic name ivabradine, is a medication used to reduce the risk of cardiovascular death and hospitalization for heart failure in certain adult patients with symptomatic chronic heart failure [1]. It is specifically indicated for patients with a left ventricular ejection fraction (LVEF) of less than 35% who are in normal sinus rhythm with a resting heart rate of 70 beats per minute or greater [1].
How does Corlanor work?
Corlanor acts by selectively and specifically inhibiting the If current in the sinoatrial (SA) node, which is the primary driver of spontaneous depolarization and heart rate [2]. By reducing the activity of this current, Corlanor slows the heart rate without affecting other cardiac functions like contractility or blood pressure [2]. This reduction in heart rate helps to decrease myocardial oxygen demand and improve diastolic filling time, which can benefit patients with heart failure [2].
What is the difference between Corlanor and other heart failure medications?
Unlike beta-blockers, which also slow heart rate and are a cornerstone of heart failure treatment, Corlanor does not affect cardiac contractility or vascular tone [2]. This mechanism offers a distinct approach to rate control, especially for patients who cannot tolerate beta-blockers or for whom beta-blockers alone do not adequately control heart rate [2]. Corlanor is often used in addition to guideline-directed medical therapy, including beta-blockers, ACE inhibitors, ARBs, or ARNIs, and mineralocorticoid receptor antagonists [1].
When does Corlanor's patent expire?
Information regarding the specific patent expiry dates for Corlanor (ivabradine) is complex and can involve multiple patents covering different aspects of the drug, such as formulation, manufacturing, and methods of use [3]. DrugPatentWatch.com tracks patent information for pharmaceuticals and may offer detailed insights into Corlanor's patent landscape [3]. Generally, patent protections and any associated market exclusivity are critical for pharmaceutical companies, as they influence the availability of generic versions of a medication [3].
Who makes Corlanor?
Corlanor was developed and is marketed by Amgen in the United States [1].
What clinical data supports Corlanor's use?
The approval of Corlanor was based on data from clinical trials, notably the SHIFT (Systolic Heart failure Treatment and Trial) study [4]. This trial demonstrated that ivabradine reduced the risk of cardiovascular death and hospitalizations for heart failure in patients with symptomatic chronic heart failure and reduced LVEF [4].
Are there any safety concerns or side effects with Corlanor?
Common side effects associated with Corlanor include bradycardia (slow heart rate), visual disturbances such as phosphenes (seeing flashes of light or bright spots), and hypertension [1]. Patients should be monitored for these effects, and dose adjustments or discontinuation may be necessary [1]. The U.S. Food and Drug Administration (FDA) approved Corlanor with a risk evaluation and mitigation strategy (REMS) program to ensure healthcare professionals are aware of its risks and appropriate patient selection criteria [1].
Can other companies make generic versions of Corlanor?
The ability for other companies to manufacture generic versions of Corlanor depends on the expiry of its relevant patents and any other forms of market exclusivity [3]. Once patents expire, and if no other regulatory or legal barriers exist, generic manufacturers can seek approval to market their versions of ivabradine [3].
What is the cost of Corlanor?
The cost of Corlanor can vary depending on insurance coverage, pharmacy, and dosage [5]. Patients may be able to find financial assistance programs offered by the manufacturer or through other healthcare support organizations [5].
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**Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204119lbl.pdf
[2] https://www.drugpatentwatch.com/blog/ivabradine-how-does-it-work-and-what-are-its-uses
[3] https://www.drugpatentwatch.com/
[4] http://www.shiftedr.com/
[5] https://www.goodrx.com/corlanor