PLAINSBORO, N.J., May 24, 2016 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a once-daily, single injection fixed combination of Tresiba® (insulin degludec injection 100 Units/mL) and Victoza® (liraglutide) injection for the treatment of adults with type 2 diabetes.
Based on the data contained in the New Drug Application (NDA) for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes.
The recommendation for approval was based on data from clinical trials of IDegLira, including the DUAL™ phase 3 clinical trial program, which involved more than 3,000 adults with type 2 diabetes. In addition to the DUAL™ clinical trial program, both insulin degludec and liraglutide have been studied extensively in separate clinical trial programs and the products are commercially available across the globe.
"We are extremely pleased that the Advisory Committee recommended unanimous approval for IDegLira and recognized that patients who require additional therapy for effective A1c control could benefit from this once-daily, single injection fixed combination treatment approach," said Todd Hobbs, M.D., U.S. chief medical officer, Novo Nordisk. "This is an important milestone for health care providers and patients, and we look forward to working with the FDA to advance the IDegLira NDA towards approval."
The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA's Prescription Drug User Fee Act V (PDUFA V) regulation. In Europe, IDegLira was approved in September 2014 and is marketed under the brand name Xultophy®.
About advisory committee meetings
FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer new drugs to an advisory committee meeting, or alternatively justify why an advisory committee meeting was not requested.
IDegLira is a once-daily, single injection fixed combination product consisting of insulin degludec (Tresiba®), a once-daily basal insulin analogue, and liraglutide (Victoza®), a once-daily GLP-1 analogue.
About Novo Nordisk
Novo Nordisk is a global health care 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. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.us or follow us on Twitter.
What is Tresiba® (insulin degludec injection)?
- Prescription Tresiba® is a long-acting insulin used to control high blood sugar in adults with diabetes
- Tresiba® is not for people with diabetic ketoacidosis
- Tresiba® is available in 2 concentrations: 200 units/mL and 100 units/mL
- It is not known if Tresiba® is safe and effective in children under 18 years of age
Important Safety Information
Do not share your Tresiba® FlexTouch® 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.
Who should not take Tresiba®?
Do not take Tresiba® if you:
- are having an episode of low blood sugar
- are allergic to Tresiba® or any of the ingredients in Tresiba®
Before taking Tresiba®, tell your health care provider about all your medical conditions, including if you are:
- pregnant, planning to become pregnant, or are breastfeeding
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements
Talk to your health care provider about low blood sugar and how to manage it.
How should I take Tresiba®?
- Read the Instructions for Use and take Tresiba® exactly as your health care provider tells you to
- Do not do any conversion of your dose. The dose counter always shows the selected dose in units
- Know the type and strength of insulin you take. Do not change the type of insulin you take unless your health care provider tells you to
- If you miss or are delayed in taking your dose of Tresiba®:
- Take your dose as soon as you remember, then continue with your regular dosing schedule
- Make sure there are at least 8 hours between doses
- Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them
- Do not reuse or share your needles with other people. You may give them a serious infection, or get a serious infection from them
- Never inject Tresiba® into a vein or muscle
- Never use a syringe to remove Tresiba® from the FlexTouch® pen
What should I avoid while taking Tresiba®?
- Do not drive or operate heavy machinery, until you know how Tresiba® affects you
- Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol
What are the possible side effects of Tresiba®?
Tresiba® may cause serious side effects that can be life-threatening, including:
- Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache
- Low potassium in your blood (hypokalemia)
- Heart failure in some people if taken with thiazolidinediones (TZDs). This can happen even if you have never had heart failure or heart problems. If you already have heart failure, it may get worse while you take TZDs with Tresiba®. Tell your health care provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet, and sudden weight gain
Your insulin dose may need to change because of change in level of physical activity or exercise, increased stress, change in diet, weight gain or loss, or illness.
Common side effects may include reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.
Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.
Please click here for Prescribing Information.
About Victoza® (liraglutide) injection
Indication and Usage
What is Victoza®?
Victoza® is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.
- Victoza® is not recommended as the first choice of medicine for treating diabetes.
- It is not known if Victoza® can be used in people who have had pancreatitis.
- 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 itching, rash, or difficulty breathing.
The most common side effects of Victoza® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.
FlexTouch®, Tresiba®, and Victoza® are registered trademarks of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2016 Novo Nordisk All rights reserved. USA16XUM01203 May 2016
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SOURCE Novo Nordisk