The FDA has officially approved Rybelsus, the first oral semaglutide, for managing type 2 diabetes. This approval represents a groundbreaking achievement in diabetes treatment. Rybelsus stands out as the first “protein”-based diabetes medication that patients can take orally rather than through injections.
This innovation became possible thanks to the SNAC compound, a key breakthrough in drug delivery. SNAC works by shielding semaglutide from the stomach’s acidic environment, which would otherwise degrade the molecule. It also facilitates semaglutide’s safe transport across gastrointestinal epithelial cells, ensuring it reaches the bloodstream intact and effective.
Extensive clinical trials under the PIONEER program demonstrated the benefits of Rybelsus for type 2 diabetes. These studies consistently showed significant improvements in A1c levels, helping patients achieve better blood sugar control. They also highlighted the added benefit of weight loss, a key consideration for many managing type 2 diabetes. These outcomes directly influenced the FDA’s decision to approve this first-of-its-kind oral treatment.
Rybelsus comes in three dosage options: 3 mg, 7 mg, and 14 mg tablets. Patients begin with a 3 mg daily dose for one month to allow their bodies to adjust. After this, they can transition to the 7 mg dose, with the option to increase to 14 mg if needed. To ensure optimal effectiveness, patients must take Rybelsus on an empty stomach with no more than 4 ounces of plain water. It’s essential to wait at least 30 minutes before eating breakfast or drinking anything other than water.
Like other GLP-1 receptor agonists, Rybelsus may cause gastrointestinal side effects, such as nausea, diarrhea, or vomiting. Providers should carefully evaluate patients with a history of gastrointestinal issues before prescribing it. Patients with a personal or family history of medullary thyroid carcinoma should not take Rybelsus. Providers should also exercise caution with patients at risk for pancreatitis, diabetic retinopathy, or kidney injury. Regular monitoring can help minimize potential risks and optimize the treatment’s benefits.
Rybelsus offers a significant new option for type 2 diabetes management, providing effective treatment in a convenient oral form. This innovation marks a new era in diabetes care, offering greater flexibility for patients who previously relied on injections.
FDA APPROVAL, 2019
The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.
“Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “Before this approval, patients did not have an oral GLP1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.”
- It is not known whether Rybelsus can be used by patients who have had pancreatitis.
- The risk of hypoglycemia increased when Rybelsus was used in combination with sulfonylureas or insulin.
- Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had MTC are advised not to use Rybelsus.
- Additionally, patients who have ever had an endocrine system condition called multiple endocrine neoplasia syndrome type 2 (MEN 2) are advised not to use Rybelsus.
- Rybelsus is not for use in patients with type 1 diabetes and people with diabetic ketoacidosis.
- Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. GLP-1, which is a normal body hormone, is often found in insufficient levels in type 2 diabetes patients. Like GLP-1, Rybelsus slows digestion, prevents the liver from making too much sugar, and helps the pancreas produce more insulin when needed.