Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg, a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. OZEMPIC® is administered once weekly, on the same day each week, and can be taken any time of the day, with or without meals.

The approval of OZEMPIC® is based on the results from a Phase 3a clinical trial program. In people with type 2 diabetes, OZEMPIC® showed clinically meaningful and statistically significant reductions in A1c compared with placebo, sitagliptin and exenatide extended-release.1 As a secondary endpoint in the trials, treatment with OZEMPIC® resulted in reductions in body weight. The most common adverse reactions reported in ≥5% of patients treated with OZEMPIC® are: nausea, vomiting, diarrhea, abdominal pain and constipation.

"The OZEMPIC® approval builds on Novo Nordisk's commitment to offering healthcare professionals a range of treatments that effectively addresses the complex needs of diabetes management and fits their patients' lifestyles," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "We are grateful to the many adults with type 2 diabetes who participated in the studies, as well as the clinical trial investigators. Thanks to their collective contributions, Novo Nordisk is able to bring once-weekly OZEMPIC® to the type 2 diabetes community."

OZEMPIC® is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the OZEMPIC® pre-filled pen.

The global Phase 3a clinical trial program for OZEMPIC® comprised eight clinical trials involving more than 8,000 adults with type 2 diabetes, including a two-year cardiovascular outcomes trial that evaluated safety in adults with type 2 diabetes at high risk of cardiovascular events.1

"Type 2 diabetes is a serious condition that affects more than 28 million people in the U.S., and despite advancements in treatment, some people with type 2 diabetes do not achieve their A1c goals," said Helena Rodbard, MD, FACP, MACE, medical director, Endocrine and Metabolic Consultants, Rockville, MD, and past president of the American Association of Clinical Endocrinologists. "The approval of semaglutide offers healthcare professionals an important new treatment option to help adults with type 2 diabetes meet their A1c goals."

Novo Nordisk expects to launch OZEMPIC® in the U.S. in Q1 2018, with a goal of ensuring broad insurance coverage and patient access to the product. OZEMPIC® will be priced at parity to current market-leading weekly GLP-1 receptor agonists and will be offered with a savings card program to reduce co-pays for eligible commercially-insured patients. Additionally, as part of the access strategy, Novo Nordisk is working with appropriate health insurance providers to establish innovative contracting solutions.

Semaglutide is currently under review by the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

What is OZEMPIC®?

OZEMPIC® (semaglutide) injection 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

OZEMPIC® is not recommended as the first choice of medicine for treating diabetes.

It is not known if OZEMPIC® can be used in people who have had pancreatitis.

OZEMPIC® 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 OZEMPIC® is safe and effective for use in children under 18 years of age.

Important Safety Information

Do not share your OZEMPIC® 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 is the most important information I should know about OZEMPIC®?

OZEMPIC® may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your healthcare 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 rodents, OZEMPIC® and medicines that work like OZEMPIC® caused thyroid tumors, including thyroid cancer. It is not known if OZEMPIC® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

Do not use OZEMPIC® 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).

Do not use OZEMPIC® if:

you or any of your family have ever had MTC or if you have MEN 2.

you are allergic to semaglutide or any of the ingredients in OZEMPIC®.

Before using OZEMPIC®, tell your health care provider if you have any other medical conditions, including if you:

have or have had problems with your pancreas or kidneys.

have a history of diabetic retinopathy.

are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if OZEMPIC® will harm your unborn baby or passes into your breast milk. You should stop using OZEMPIC® 2 months before you plan to become pregnant.

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 OZEMPIC®

OZEMPIC® is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject OZEMPIC® into a muscle (intramuscularly) or vein (intravenously).

Do not mix insulin and OZEMPIC® together in the same injection.

Change (rotate) your injection site with each injection. Do not use the same site for each injection.

Talk to your healthcare provider about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.

What are the possible side effects of OZEMPIC®?

OZEMPIC® may cause serious side effects, including:

inflammation of your pancreas (pancreatitis). Stop using OZEMPIC® 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.

changes in vision. Tell your healthcare provider if you have changes in vision during treatment with OZEMPIC®.

low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use OZEMPIC® 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. It is important for you to drink fluids to help reduce your chance of dehydration.

serious allergic reactions. Stop using OZEMPIC® 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 OZEMPIC® may include nausea, vomiting, diarrhea, stomach (abdominal) pain, and constipation.