Servier Canada Release: Health Canada Approves New Heart Failure Treatment LANCORA To Reduce Mortality And Hospitalizations

LAVAL, QC, Jan. 10, 2017 /CNW Telbec/ - Health Canada has issued a Notice of Compliance for LANCORA (ivabradine), a new treatment shown to reduce mortality and hospitalizations in patients suffering from chronic heart failure. LANCORA is a first-in-class treatment which lowers the heart rate, and is indicated on top of standard treatment in stable chronic heart failure patients with a heart rate of 77 beats per minute or higher and with reduced left ventricular ejection fraction ( 35%) in NYHA Classes II or III.

Heart failure rates continue to rise in Canada and it is a major cause of illness, hospitalizations and death. Heart failure is a complex and incurable condition, resulting in the heart not being able to pump sufficient blood to meet the body's demands. Heart rate appears to play a crucial role in heart failure.  A high heart rate is associated with higher mortality and hospital readmissions (risk marker), while a reduction of heart rate on those same patients suffering from heart failure reduces the incidence of those events (risk factor).ⁱ This cardiac disease is responsible for 9% of all deaths in Canadaⁱⁱ, about 22,500 per yearⁱⁱⁱ, which is almost equal to the deaths from breast, colorectal, prostate and pancreatic cancer combined.^iv

"Heart Failure is a chronic condition that affects approximately 600,000 Canadians and their families. This condition can be managed with effective new therapies that are coming to us now, which make this an exciting time. The recent approval of drugs such as ivabradine, is a major step in the right direction," said Dr. Jonathan Howlett, Past President of the Canadian Heart Failure Society and Clinical Professor of Medicine at the Libin Cardiovascular Institute of Alberta in Calgary.

"There remains a major gap in the treatment of our patients with heart failure today, particularly those patients with a fast heartbeat," said Dr. Peter Liu, Chief Scientific Officer and Vice President of Research at the University of Ottawa Heart Institute. "The consequence of an elevated heart rate is an increased risk of dying from heart failure, even when treated with other heart failure medicines. With the recent approval of ivabradine, we will soon have a new therapeutic option to keep more of our patients alive and out of the hospital longer."

The approval of LANCORA is based on a complete clinical development program, including the SHIFT trial, a large, multicenter, randomized, double-blind, placebo-controlled, outcomes trial which compared the treatment effect (on top of current standard treatment) of LANCORA vs Placebo in 6,505 heart failure patients with elevated heart rate.^v

"We are excited and proud that Canadian patients as well as clinicians involved in the management of heart failure will now have access to this first in class treatment that has already improved the life of many patients throughout the world. Servier Canada is now working diligently to ensure that Lancora^TM will be available in retail pharmacies and hospitals across Canada in the coming weeks," underlined Frederic Fasano, Chief Executive Officer of Servier Canada.

About LANCORA and the SHIFT study^vi

LANCORA is a first-in-class treatment that lowers the heart rate by reducing the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I_f current ("funny" current) to slow the heart rate with no effect on ventricular repolarization and no effects on myocardial contractility.vii LANCORA (ivabradine) is indicated for the treatment of stable chronic heart failure with reduced left ventricular ejection fraction ( 35%) in adult patients with NYHA Classes II or III who are in sinus rhythm with a resting heart rate 77 beats per minute, to reduce the incidence of cardiovascular mortality and hospitalizations for worsening heart failure.

The SHIFT study (Systolic Heart failure treatment with the I_finhibitor ivabradine Trial) is an international clinical trial that followed more than 6,505 heart failure patients at 625 centers in 37 countries with an active double-blind treatment period from 12 to 36 months. Patients with symptomatic heart failure with a left ventricular ejection fraction of 35% or lower and in sinus rhythm, with a heart rate of 70 beats per minute or more documented by standard 12-lead ECG and on stable background treatment for heart failure were randomized to add either LANCORA or placebo to standard of care therapies. Standard treatment included beta blockers (89%), angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blockers (ARB) (91%), diuretics (83%), anti-aldosterone agents (60%) and digoxin (22%). LANCORA significantly reduced the risk of the primary composite endpoint of cardiovascular death or hospitalization for worsening heart failure, with an 18% relative risk reduction, and a 4.2 percent absolute risk reduction versus placebo.

About Servier Canada
Servier Canada Inc. is an affiliate of the independent French Servier Group. Its mission is to provide the Canadian medical community and its patients innovative therapeutic solutions. As such, Servier Canada collaborates with various players in the healthcare system including researchers, entrepreneurs and innovators. In addition to these research partners, the Canadian International Center for Therapeutic Research (ICTR) is dedicated to clinical development with more than 50 studies conducted throughout Canada over the last 10 years. More information is available at www.servier.ca

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ⁱ Reil JC, Custodis F, Swedberg K et al. Heart rate reduction in cardiovascular disease and therapy. Clin Res Cardiol 2011;100(1):11-19.
ⁱⁱ Brophy JM. Epidemiology of congestive heart failure: Canadian data from 1970 to 1989. Can J Cardiol 1992;8:495-498.
ⁱⁱⁱ Statistics Canada, Leading Causes of deaths in Canada, 2009, CANSIM Table 102-0561.
^iv Canadian Cancer Society, Canadian Cancer Statistics, 2015, p. 47.
^v Swedburg K et al, Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study, The Lancet, Volume 376, Issue 9744, Pages 875-885, 11 September 2010.
^vi Swedburg K et al, Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study, The Lancet, Volume 376, Issue 9744, Pages 875-885, 11 September 2010.
^vii Amgen, Press Release, FDA approves Corlanor® (ivabradine) to reduce the risk of hospitalization for worsening heart failure in patients with chronic heart failure, April 15, 2015.

SOURCE Servier Canada Inc.