The first diabetes pill ever gets FDA approval to be used in the U.S.

Novo Nordisk announced on September 20th U.S. Food and Drug Administration (FDA) approval for Rybelsus® (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes. Along with diet and exercise, the drug may improve blood sugar (glucose) levels. 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. Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, remarked “now patients will have a new option for treating type 2 diabetes without injections.”

Type 2 diabetes, a global public health issue 

Even though type 1 diabetes-related research has registered significant advances, people living with type 2 diabetes also deserve innovative new drugs to help them manage their condition.

More than 30 million Americans have diabetes (about 1 in 10), and 90% to 95% of them have type 2 diabetes. Type 2 diabetes most often develops in people over age 45, but increasing numbers of children, teens, and young adults are being diagnosed. Although treatment options are available, it sometimes becomes difficult for adults who have type 2 diabetes to effectively manage their blood sugar. This increases the risk of developing serious diabetes-related complications.

“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 the 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 was approved after 10 clinical trials

The approval of Rybelsus® is based on results from 10 PIONEER clinical trials with 9,543 participants, including 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 adverse reactions were similar across trials. 

“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.”

Rybelsus® is now being reviewed by several regulatory agencies around the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.

The drug will be available in the U.S. starting with the fourth quarter 

Rybelsus® is approved for once-daily use in two therapeutic doses, 7 mg, and 14 mg. Manufacturing facilities in Denmark will provide the initial supply of Rybelsus®,  but in the future, Rybelsus® will be produced in the U.S. In 2015, Novo Nordisk made a strategic investment to build a new manufacturing facility in Clayton, NC in preparation for the anticipated demand for Rybelsus®. Earlier this year Novo Nordisk also bought a tableting and packaging facility in Durham, NC to meet the eventual expected Rybelsus demand. 

According to Novo Nordisk, Rybelsus would be available in the US starting with the fourth quarter. The company is working with health insurers to find solutions for “broad” coverage, hoping to ensure patient access to the product. The therapy will be “competitively priced within the GLP-1 category,” the company said, adding that “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.

What is Rybelsus?

Rybelsus® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine for adults with type 2 diabetes. Together with diet and exercise, the drug 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 by people who have had pancreatitis
• Rybelsus® is not for use by people with type 1 diabetes and people with diabetic ketoacidosis
• It is not known if Rybelsus® is safe and effective for use by children under 18 years of age

What are the possible side effects of Rybelsus?

Patients have to inform their healthcare providers about any other medical issues they might have before using Rybelsus®. Healthcare providers need to be informed about all the drugs a patient takes, either prescription or over-the-counter medicines, vitamins, and herbal supplements. Rybelsus® may affect the way some medicines work; likewise, some medicines may affect the way Rybelsus® works.

The most common side effects of Rybelsus could include nausea, stomach (abdominal) pain, diarrhea, appetite loss, vomiting, and constipation. 

More serious side effects might occur, including:

• inflammation of your pancreas (pancreatitis)
• changes in vision
• low blood sugar (hypoglycemia). 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)
• 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

Rybelsus® could also cause thyroid tumors, including cancer. If patients get a lump or swelling in the neck, hoarseness, experience trouble swallowing, or shortness of breath, they should inform their healthcare provider. 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.

About Rybelsus®

Rybelsus® (semaglutide) tablets 7 mg or 14 mg is an analog of the naturally occurring hormone glucagon-like peptide-1 (GLP-1). Rybelsus® is the first and only GLP-1 receptor agonist (RA) in a pill. It is administered once daily and is approved for use in two therapeutic doses: 7 mg and 14 mg.

About Novo Nordisk

Novo Nordisk is a global healthcare company that has been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country.