Novo Nordisk A/S’s Victoza Beats Sanofi’s Lixisenatide in Head-to-Head Study, Company Says
Published: Sep 17, 2015
September 16, 2015
By Alex Keown, BioSpace.com Breaking News Staff
STOCKHOLM – Novo Nordisk reported today that its type 2 diabetes treatment Victoza in combination with metformin, proved superior in reducing HbA1c than Sanofi’s lixisenatide in combination with metformin.
Novo’s jumped slightly this morning to a price of $56.37, up from its opening $55.94 per share.
In the head-to-head trial, which surveyed 404 patients over a 26-week period, Victoza was administered once daily at any time irrespective of meals while lixisenatide was administered once-daily within an hour prior to the morning or evening meal, Novo said.
Patients treated with Victoza achieved a significantly greater reduction in HbA1c versus lixisenatide, the company said in a statement. The Victoza patients saw a 1.83 percent reduction of their HbA1c levels as opposed to those treated with the Sanofi drug, who saw a 1.21 percent reduction. HbA1c is short for glycated hemoglobin. Individuals diagnosed with diabetes monitor their HbA1c levels. The higher the level, means a higher blood sugar level, which can lead to greater risk of developing diabetes-related issues. In non-diabetic patients, the HbA1c level should be less than 7 percent of total hemoglobin. Keeping the HbA1c levels as close to 7 percent as possible can delay or prevent diabetic complications, which makes a reduction of nearly 2 percent highly successful. According to Novo, more patients treated with achieved Hb1Ac targets of less than 7 percent in comparison to Sanofi’s lixisenatide. The results, which were presented at the 51st Annual Meeting of the European Association for the Study of Diabetes in Sweden this week, showed 74.2 percent of Victoza patients fell below that important 7 percent line, as opposed to percent of those taking lixisenatide, the company said.
“Many people living with type 2 diabetes remain uncontrolled and it is crucial for these patients to gain control of their blood glucose levels to help prevent further complications from this disease.” Michael Nauck, director of the Division of Diabetology at St. Josef Hospital in Bochum, Germany and one of the investigators of the trial, said in a statement.
Victoza, a GLP-1 analog, was launched in the European Union in 2009. A version was approved by the U.S. Food and Drug Administration (FDA) under the brand name Saxenda in December 2014. In April, Novo Nordisk announced Saxenda was available for sale in the United States. Obese individuals often develop type 2 diabetes.
In August, Novo pulled the plug on expanding the use of Victoza for type 1 diabetes patients. In the latest study, dubbed Adjunct One, Victoza (liraglutide) combined with an insulin improved blood glucose control in attempts to treat type 1 diabetes actually worsened episodes of low blood sugar, the company reported. For one year 1,400-person trial patients were treated with daily doses of three strengths of the Victoza combination at 0.6 mg, 1.2 mg and 1.8 mg, or a placebo. Patients treated with the higher doses of the combination reduced HbA1c and also assisted in greater weight loss than placebo. However, the .6 mg dosage had results lower than the placebo group, the company said. The rate of severe hypoglycemia was not statistically lower than the placebo group for patients treated with all three dosage levels.
Earlier this year, the company said it plans on ramping up production of insulin to more than double its current output as more and more diagnoses of diabetes are made. In 2012 nearly 10 percent of the U.S. population had been diagnosed with some form of diabetes, according to the American Diabetes Association. Type 2 diabetes is on the rise in the United States, driven partly by the increase in the waistlines of Americans. A 2014 study published in the Annals of Internal Medicine showed a steady increase in diagnoses of the disease over the past decade.