Novo Nordisk files for US FDA approval of oral semaglutide for blood sugar control and cardiovascular risk reduction in adults with type 2 diabetes

Novo Nordisk also files sNDA with US FDA for cardiovascular risk reduction for Ozempic® in adults with type 2 diabetes and established cardiovascular disease

News provided by

Novo Nordisk

Mar 20, 2019, 10:08 ET

PLAINSBORO, N.J., March 20, 2019 /PRNewswire/ -- Novo Nordisk today announced the submission of two New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for oral semaglutide, the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist in a pill. One NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with type 2 diabetes. Novo Nordisk has submitted a priority review voucher (PRV) for this NDA with an anticipated review time of six months. The second NDA for oral semaglutide seeks approval for an indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or death in adults with type 2 diabetes and established cardiovascular disease (CVD) and has an anticipated 10-month review time.

Additionally, Novo Nordisk filed a supplemental NDA (sNDA) for once-weekly Ozempic^®(semaglutide) injection 0.5 mg or 1 mg. The company is pursuing an indication to reduce the risk of MACE such as heart attack, stroke, or death in adults with type 2 diabetes and established CVD. The Ozempic^® sNDA has an anticipated 10-month review time. Ozempic^® was FDA approved on Dec 5, 2017 for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

"We are very excited about these three regulatory filings with the FDA as they represent a significant milestone for the company, but most importantly represent new potential treatment options for adults living with type 2 diabetes," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "We know that many adults with type 2 diabetes are still struggling to control their blood sugar and are at increased cardiovascular risk. We hope that, if approved, these products can help those patients."

The efficacy and safety of oral semaglutide was evaluated in 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the PIONEER program, people treated with oral semaglutide were compared to those taking sitagliptin, empagliflozin, liraglutide, and placebo.

The applications for the oral semaglutide and Ozempic^® cardiovascular risk reduction indications are based on the results of two cardiovascular outcomes trials (CVOTs) examining the effects of adding semaglutide or placebo to standard of care on the risk of MACE in adults with type 2 diabetes and established CVD; PIONEER 6 with oral semaglutide and SUSTAIN 6 with Ozempic^®.

About the PIONEER clinical trial program
PIONEER is a global clinical trial program for oral semaglutide that comprises 10 Phase 3a clinical trials including a CVOT, involving 9,543 adults with type 2 diabetes.

About PIONEER 6 and SUSTAIN 6
PIONEER 6 was an event-driven, pre-approval CVOT for oral semaglutide. It was a randomized, double-blinded, placebo-controlled trial evaluating the cardiovascular safety of oral semaglutide vs placebo when added to standard of care in 3,183 adults with type 2 diabetes with established CVD or high risk of cardiovascular events.

SUSTAIN 6 was an event- and time-driven, pre-approval CVOT for Ozempic^®. It was a randomized, double-blinded, placebo-controlled trial evaluating the cardiovascular safety of Ozempic^® vs placebo when added to standard of care in 3,297 adults with type 2 diabetes with established CVD or high risk of cardiovascular events.

About Ozempic^®Ozempic^® (semaglutide) injection 0.5 mg or 1 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.¹ Ozempic^® was approved by the US Food and Drug Administration on December 5, 2017, by Health Canada on January 4, 2018, by the European Commission on February 9, 2018, by the Japanese Ministry of Health, Labour and Welfare on March 23, 2018, by Swissmedic on July 2, 2018, and by the Brazilian National Health Surveillance Agency on August 6, 2018.^2-7

About the SUSTAIN clinical trial program
The SUSTAIN clinical development program for Ozempic^® comprises 10 Phase 3 global clinical trials, including a CVOT, which included adults with type 2 diabetes with established CVD or high risk of cardiovascular events. The program involves more than 8,700 adults with type 2 diabetes in total (includes people from SUSTAIN 1-7 and 9).

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 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 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.

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 health care 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.

Please see Medication Guide and Prescribing Information, including Boxed Warning for Ozempic^®, at http://www.novo-pi.com/ozempic.pdf.

About Novo Nordisk
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

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