PLAINSBORO, N.J., Aug. 25, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza® (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.1
The FDA's decision is based on the results from the landmark LEADER trial, which demonstrated that Victoza® significantly reduced the risk of a three component endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo (p=0.01) with an absolute risk reduction (ARR) of 1.9%.1
"Physicians have come to rely on Victoza® as an effective therapy for lowering A1C, and with this new indication, they now have the option to choose a diabetes medication that also reduces their patient's cardiovascular risk," said Anne Phillips, Senior Vice President, Clinical, Medical and Regulatory Affairs for Novo Nordisk. "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."
Cardiovascular disease is the leading cause of morbidity and mortality in patients with diabetes.2 Studies have shown that adults with type 2 diabetes are up to four times more likely to develop cardiovascular disease.3 Victoza® demonstrated a life-saving benefit that included a 22% reduction in cardiovascular death and a 15% reduction in all-cause death (ARR 1.3%, 1.4% respectively).
"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," said Steve Marso, MD, Medical Director, Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER. "More treatment options like Victoza® that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."
About Victoza® Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is commercially available in 95 countries, treating more than 1 million people with type 2 diabetes globally.4
About the LEADER trial LEADER was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of Victoza® (liraglutide) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major adverse cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.5
The landmark LEADER trial was initiated in September 2010 and randomized 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprised of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.5
Indication and Usage
What is Victoza®? Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine for adults with type 2 diabetes that:
along with diet and exercise may improve blood sugar (glucose).
along with your current treatment for your cardiovascular disease may reduce the risk of major cardiovascular events such as heart attack, stroke, or death.
Victoza® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza® can be used with mealtime insulin. It is not known if Victoza® is safe and effective for use in children.
Important Safety Information
What is the most important information I should know about Victoza®? Victoza® may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Who should not use Victoza®? Do not use Victoza® if:
you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you are allergic to liraglutide or any of the ingredients in Victoza®.
What should I tell my health care provider before using Victoza®? Before using Victoza®, tell your health care provider if you:
have or have had problems with your pancreas, kidneys, or liver.
have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Victoza®?
Do not mix insulin and Victoza® together in the same injection.
You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
Do not share your Victoza®pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:
inflammation of your pancreas (pancreatitis). Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
serious allergic reactions. Stop using Victoza® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or a very rapid heartbeat.
gallbladder problems. Gallbladder problems have happened in some people who take Victoza. Tell your healthcare provider right away if you get symptoms of gallbladder problems which may include pain in the right or middle upper stomach area, fever, nausea and vomiting, or your skin or the white part of your eyes turns yellow.
Themostcommon side effects Victoza®may include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.
About Novo Nordisk Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc; August 2017.
Low Wang CC, Hess CN, Hiatt WR, Goldfine AB. Clinical Update: cardiovascular disease in diabetes mellitus. Atherosclerotic cardiovascular disease and heart failure in type 2 diabetes mellitus–mechanisms, management, and clinical considerations. Circulation. 2016; 133:2459-2502.