BAGSVAERD, Denmark and PLAINSBORO, N.J., June 13, 2013 /PRNewswire/ -- Today, Novo Nordisk presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the U.S. arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI). At the two-day workshop, regulators, academic and scientific experts as well as representatives from the pharmaceutical industry came together to discuss suspected mechanisms linking pancreatitis, diabetes and pancreatic cancer.
At the workshop, Solomon Iyasu, MD, director of the division of Epidemiology, U.S. Food and Drug Administration (FDA), presented the FDA's approach to address and assess pancreatic safety of the incretin mimetic class of diabetes drugs (GLP-1 receptor agonists and DPP-IV inhibitors). In Dr. Iyasu's presentation, the FDA stated that review of epidemiological studies submitted to the FDA and published in journals has provided conflicting results and does not provide reliable evidence to refute or support a causal link between incretin mimetics and the risk of acute pancreatitis. Consequently, FDA concluded, that an evaluation of a potential association between incretin mimetics and pancreatitis and pancreatic cancer would require adequately powered long-term epidemiological studies.
At the workshop, Novo Nordisk presented interim data from an on-going prospective, matched cohort epidemiological study comparing Victoza® with four other widely used anti-diabetic drug classes in each cohort. The study comprised more than 100,000 patient years of treatment, with between 14,000 and 19,000 patients on Victoza® and comparator treatment in each cohort. The results of the study were presented as part of a complete overview of available Victoza® safety data, including non-clinical and clinical data as well as data from post-marketing commitments that together reconfirmed the safety profile of Victoza®.
"We remain very confident in the safety profile of Victoza®, which has been extensively studied throughout the development and marketing phases," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, "Our confidence in the positive benefit-risk profile of Victoza® is reassured by the interim data from the prospective epidemiological study presented today."
Novo Nordisk is dedicated to the continued monitoring and reporting on the safety profile of Victoza® and will work with health authorities, scientific experts, diabetes associations and other stakeholders to ensure that patients and physicians have a clear understanding of the benefit-risk profile of the product.
Indications and Usage:
Victoza® (liraglutide [rDNA origin] injection) is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes when used along with diet and exercise.
Victoza® is not recommended as the first medication to treat diabetes. Victoza® has not been studied in patients with history of inflammation of the pancreas (pancreatitis). Victoza® is not a substitute for insulin and has not been studied in combination with prandial (meal-time) insulin. Victoza® is not for people with type 1 diabetes or people with diabetic ketoacidosis. It is not known if Victoza® is safe and effective in children. Victoza® is not recommended for use in children.
Important Safety Information:
In animal studies, Victoza® caused thyroid tumors -- including thyroid cancer -- in some rats and mice. It is not known whether Victoza® causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people, which may be fatal if not detected and treated early. Do not use Victoza® if you or any of your family members have a history of MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). While taking Victoza®, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
Do not use Victoza® if you are allergic to liraglutide or any of the ingredients in Victoza®. Serious allergic reactions can happen with Victoza®. If symptoms of serious allergic reactions occur, stop taking Victoza® and seek medical attention. Pancreatitis may be severe and lead to death. Before taking Victoza®, tell your doctor if you have had pancreatitis, gallstones, a history of alcoholism, or high blood triglyceride levels since these medical conditions make you more likely to get pancreatitis.
Stop taking Victoza® and call your doctor right away if you have pain in your stomach area that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.
Before using Victoza®, tell your doctor about all the medicines you take, especially sulfonylurea medicines or insulin, as taking them with Victoza® may affect how each medicine works. If you use Victoza® with insulin, you may give both injections in the same body area (for example, your stomach area), but not right next to each other.
Also tell your doctor if you have severe stomach problems such as slowed emptying of your stomach (gastroparesis) or problems with digesting food; have or have had kidney or liver problems; have any other medical conditions; or are pregnant or plan to become pregnant. Tell your doctor if you are breastfeeding or plan to breastfeed. It is unknown if Victoza® will harm your unborn baby or if Victoza® passes into your breast milk.
Your risk for getting hypoglycemia, or low blood sugar, is higher if you take Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. The dose of your sulfonylurea medicine or insulin may need to be lowered while taking Victoza®.
Victoza® may cause nausea, vomiting, or diarrhea leading to dehydration, which may cause kidney failure. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration.
The most common side effects with Victoza® include headache, nausea, and diarrhea. Nausea is most common when first starting Victoza®, but decreases over time in most people. Immune system related reactions, including hives, were more common in people treated with Victoza® compared to people treated with other diabetes drugs in medical studies.
Please click here for Prescribing Information and Medication Guide.
Headquartered in Denmark, Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. For more information, visit novonordisk.com.
SOURCE Novo Nordisk