FDA Approves Rybelsus

FDA Approves Rybelsus (semaglutide), the First Oral GLP-1 Analog Treatment for Adults with Type 2 Diabetes

PLAINSBORO, N.J., Sept. 20, 2019 /PRNewswire/ -- Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).1 Rybelsus is the first and only glucagon-like peptide-1 (GLP-1) analog in a pill and a new option for adults with type 2 diabetes who are not achieving their A1C goal with current antidiabetic treatment.

Type 2 diabetes is a global public health issue that impacts more than 28 million people in the U.S. alone.2 Despite existing treatment options, many adults with type 2 diabetes have poorly managed blood sugar that can increase the risk of developing serious diabetes-related complications.2-3

"GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment," said Vanita R. Aroda, MD, Director of Diabetes Clinical Research, Brigham and Women's Hospital, Boston, MA and a PIONEER clinical trial investigator. "The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals."

The approval of Rybelsus is based on results from 10 PIONEER clinical trials, which enrolled 9,543 participants and included head-to-head studies of Rybelsus vs. sitagliptin, empagliflozin and liraglutide 1.8 mg.4 In the trials, Rybelsus reduced A1C and, as a secondary endpoint, showed reductions in body weight. The most common adverse reactions in the PIONEER trials, reported in ≥5% of patients, were nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation. The types and frequency of the adverse reactions were similar across trials.1,5-7

"People living with type 2 diabetes deserve more innovation, research and support to help them achieve their individual A1C goals," said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. "With Rybelsus, we have the opportunity to expand use of effective GLP-1 receptor agonist therapy by providing adults with type 2 diabetes an oral medication which was previously only available as an injection to help with managing their blood sugar."

Rybelsus is approved for once-daily use in two therapeutic doses, 7 mg and 14 mg, and will be available in the U.S. beginning in Q4 2019. Initial supply of Rybelsus will come from manufacturing facilities in Denmark; however, future supply for Rybelsus will come from manufacturing facilities in the U.S. In 2015, Novo Nordisk made a strategic investment to build a new manufacturing facility in Clayton, NC to prepare for the future demand for Rybelsus. Additionally, earlier this year Novo Nordisk acquired a tableting and packaging facility in Durham, NC to meet anticipated supply needs for Rybelsus.

Novo Nordisk is working with health insurance providers with a goal of ensuring broad insurance coverage and patient access to the product. A savings card program will be available at the time of launch for eligible commercially-insured patients to keep out of pocket costs down to as little as $10 a month.

The U.S. FDA is still reviewing Novo Nordisk's new drug application (NDA) for Rybelsus seeking an additional indication to reduce the risk of major adverse cardiovascular events (MACE) such as heart attack, stroke, or cardiovascular death in adults with type 2 diabetes and established cardiovascular disease (CVD). A decision is expected in Q1 2020.

Rybelsus is currently under review by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

What is Rybelsus?

Rybelsus (semaglutide) tablets 7 mg or 14 mg is a prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).

• Rybelsus is not recommended as the first choice of medicine for treating diabetes
• It is not known if Rybelsus can be used in people who have had pancreatitis
• Rybelsus is not for use in people with type 1 diabetes and people with diabetic ketoacidosis
• It is not known if Rybelsus is safe and effective for use in children under 18 years of age

• Important Safety Information

  What is the most important information I should know about Rybelsus?

  Rybelsus 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, Rybelsus and medicines that work like Rybelsus caused thyroid tumors, including thyroid cancer. It is not known if Rybelsus will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

  Do not use Rybelsus 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 semaglutide or any of the ingredients in Rybelsus

  Before using Rybelsus, tell your healthcare 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 vision problems related to your diabetes
  • are pregnant or plan to become pregnant. It is not known if Rybelsus will harm your unborn baby. You should stop using Rybelsus 2 months before you plan to become pregnant. Talk to your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant
  • are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with Rybelsus.

  Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rybelsus may affect the way some medicines work and some medicines may affect the way Rybelsus works.

  How should I take Rybelsus?

  • Take Rybelsus exactly as your healthcare provider tells you to
  • Take Rybelsus by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)
  • Do not split, crush, or chew. Swallow Rybelsus whole
  • After 30 minutes, you can eat, drink, or take other oral medications. Rybelsus works best if you eat 30 to 60 minutes after taking it
  • If you miss a dose of Rybelsus, skip the missed dose and go back to your regular schedule

  What are the possible side effects of Rybelsus?

  Rybelsus may cause serious side effects, including:

  • inflammation of your pancreas (pancreatitis). Stop using Rybelsus and call your healthcare 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 Rybelsus
  • low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Rybelsus 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 Rybelsus 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 Rybelsus may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start Rybelsus.