Corporate News Blog - Novo Nordisk’s Victoza(R) Receives Approval from FDA
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LONDON, UK / ACCESSWIRE / August 29, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Novo Nordisk A/S (NYSE: NVO), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=NVO. The Company announced on August 25, 2017, that the US Food and Drug Administration (FDA) approved a new indication for its Victoza® (liraglutide) to lessen the risk of main adverse cardiovascular events in adults with type-2 diabetes and established cardiovascular disease. This is the first time that the FDA has cleared a diabetes drug for reducing risks of heart attack, stroke, and cardiovascular deaths in patients with type-2 diabetes. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Approval Based on LEADER trial
The decision of the FDA has been driven by the results of the landmark LEADER trial.
LEADER trial was a multicenter, international, randomized, double-blind, placebo-controlled trial, meant to investigate the long-term (i.e. 3.5 years - 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 cardiovascular events. Wherein, the standard of care was comprised of lifestyle modifications, glucose-lowering treatments, and cardiovascular medications. The landmark LEADER trial was initiated in September 2010, and randomized about 9,340 people with type-2 diabetes from over 32 countries. Its main endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal heart attack, or non-fatal stroke.
Results from the Trial
The trial revealed that Victoza® can statistically significantly lower the risk of cardiovascular death, non-fatal heart attack, or non-fatal stroke by 13% compared to placebo, when added to standard of care, with an absolute risk reduction of 1.9%. Moreover, the overall risk reduction is based on the statistically significant 22% reduction in cardiovascular death with Victoza® treatment versus placebo, with an absolute risk reduction of 1.3%, and non-significant reductions in non-fatal heart attack and non-fatal stroke.
An Important Milestone for Diabetes Patients
Mads Krogsgaard Thomsen, Executive Vice President and Chief Science Officer at Novo Nordisk shared his views about the approval. He stated that the approval marks an important milestone for millions of Americans living with type-2 diabetes, as cardiovascular disease is the number one cause of death in this patient population. Victoza® would provide an effective treatment option to both lower blood glucose and reduce cardiovascular risk to people suffering with type-2 diabetes and established cardiovascular disease.
Anne Phillips, Senior Vice President, Clinical, Medical and Regulatory Affairs for Novo Nordisk also shared that now physicians increasingly rely on Victoza® as an effective therapy for lowering A1C. She said that with the new indication, physicians would get to choose a diabetes medication that also reduces their patient's cardiovascular risk.
Steve Marso, MD, Medical Director, Cardiovascular Services HCA Midwest Health Heart and Vascular Institute, and one of the primary investigators in LEADER also confirmed that this development is significant for millions of Americans living with type-2 diabetes because diabetes puts patients at a greater risk for cardiovascular events, even when it is in controlled levels. He mentioned that treatment options such as Victoza® address critical aspects of diabetes care over and above glucose lowering.
Link between Cardiovascular disease and type-2 diabetes
It is well known that cardiovascular disease is the leading cause of mortality in patients with diabetes. Studies have validated that adults with type-2 diabetes are up to four times more likely to develop cardiovascular disease. Moreover, according to the Center for Disease Control and Prevention, heart disease is among the main causes of death in the United States, and it claims lives of around 610,000 people every year.
Victoza® (liraglutide) Being Used Across the World
Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% akin to endogenous human GLP-1.
The drug was approved in the European Union way back in 2009. It is now commercially available in over 95 countries and treats over 1 million people with type-2 diabetes globally. On the other hand, the drug was previously approved in the US in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes. And now it is approved to reduce the risk of major adverse cardiovascular events (such as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type-2 diabetes and established cardiovascular disease. On the other hand, in Europe, Victoza® is indicated for the treatment of adults with insufficiently controlled type-2 diabetes together with diet and exercise, as monotherapy when metformin is considered inappropriate due to intolerance or contraindications and in addition to other medicinal products for the treatment of diabetes.
Last Close Stock Review
On Monday, August 28, 2017, the stock closed the trading session at $46.80, climbing 1.45% from its previous closing price of $46.13. A total volume of 1.23 million shares have exchanged hands. Novo Nordisk A/S's stock price surged 11.01% in the last one month, 11.64% in the past three months, and 32.47% in the previous six months. Furthermore, since the start of the year, shares of the Company have rallied 30.51%. The stock is trading at a PE ratio of 19.16 and has a dividend yield of 2.03%. The stock currently has a market cap of $90.98 billion.
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