FDA NewsPerspective

FDA approves expanded CV indication for Victoza

The FDA today approved an expanded indication for the GLP-1 receptor agonist liraglutide to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, myocardial infarction, stroke and cardiovascular disease in adults with type 2 diabetes and established CVD, according to a press release from Novo Nordisk.

The decision is based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide (Victoza, Novo Nordisk) compared with placebo (P = .01).

“Physicians have come to rely on Victoza as an effective therapy for lowering HbA1c, and with this new indication, they now have the option to choose a diabetes medication that also reductions their patients’ cardiovascular risk,” Anne Phillips, senior vice president of clinical, medical and regulatory affairs for Novo Nordisk, said in the release. “This is good news for patients and health care providers that will also bring much needed attention to the relationship between type 2 diabetes and cardiovascular disease.”

“Today’s news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events,” Steve Marso, MD, medical director of cardiovascular services at HCA Midwest Health Heart and Vascular Institute, said in the release. “More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are effectual to confront this pervasive issue.”

The FDA today approved an expanded indication for the GLP-1 receptor agonist liraglutide to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, myocardial infarction, stroke and cardiovascular disease in adults with type 2 diabetes and established CVD, according to a press release from Novo Nordisk.

The decision is based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide (Victoza, Novo Nordisk) compared with placebo (P = .01).

“Physicians have come to rely on Victoza as an effective therapy for lowering HbA1c, and with this new indication, they now have the option to choose a diabetes medication that also reductions their patients’ cardiovascular risk,” Anne Phillips, senior vice president of clinical, medical and regulatory affairs for Novo Nordisk, said in the release. “This is good news for patients and health care providers that will also bring much needed attention to the relationship between type 2 diabetes and cardiovascular disease.”

“Today’s news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events,” Steve Marso, MD, medical director of cardiovascular services at HCA Midwest Health Heart and Vascular Institute, said in the release. “More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are effectual to confront this pervasive issue.”

    Perspective

    Alan J. Garber

    The approval by the FDA of a major adverse cardiac events indication for a member of the GLP-1 receptor agonist class of anti-diabetic agents, specifically liraglutide (Victoza, Novo Nordisk), highly impacts our thinking about diabetes treatment. Part of the focus on metformin as early therapy for type 2 diabetes was the finding of CV benefit in the UKPDS substudy. That was an underpowered, but nonetheless surprising, finding, which drew considerable attention toward this previously controversial agent. Now, because of FDA mandates, we are accumulating considerable data regarding all new anti-diabetic agents. Two have returned results of evident CV benefit: empagliflozin and now liraglutide. In the latter instance, there is a specific MACE indication, which suggests important actions on the atherosclerotic process(es). This is different than the mortality indication granted for empagliflozin. These findings expand and empower an aggressive campaign on CV complications of diabetes, the major cause of diabetic mortality.

    • Alan J. Garber, MD, PhD, FACE
    • Chief Medical Editor of Endocrine Today
      Professor of Medicine, Biochemistry, and Molecular and Cellular Biology
      Diabetes, Endocrinology and Metabolism, Baylor College of Medicine

    Disclosures: Garber reports serving on the advisory board for Janssen, Kowa, Lexicon, Merck, Novo Nordisk, Takeda, Viking Therapeutics and Vivus and serving as a consultant for Janssen, Kowa, Lexicon, Merck, Novo Nordisk, Takeda, Viking Therapeutics and Vivus.

    Perspective
    Robert H. Eckel, MD

    Robert H. Eckel

    The FDA decision is consistent with the LEADER trial results. This provides another new opportunity for reducing major CVD events in patients with type 2 diabetes.

    • Robert H. Eckel, MD
    • Professor of Medicine
      Division of Endocrinology, Metabolism and Diabetes
      Division of Cardiology
      Professor of Physiology and Biophysics
      Charles A. Boettcher II Chair in Atherosclerosis
      University of Colorado Denver Anschtuz Medical Campus

    Disclosures: Eckel reports financial ties with Ionis Pharmaceuticals and Regeneron/Sanofi.