FDA Approves Semaglutide Pill to Treat Type 2 Diabetes
As of September 2019, Rybelsus (semaglutide) is the first pill in a class of drugs called glucagon-like peptide (GLP-1) approved for use by the FDA to treat type 2 diabetes. This oral treatment can replace semaglutide injections for some patients with the condition, although the FDA notes that it doesn’t recommend choosing Rybelsus as a first option to fight diabetes.
“Before this approval, patients did not have an oral GLP-1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections,” said Dr. Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
GLP-1 is a hormone many people with type 2 diabetes sometimes produce small amounts of. Rybelsus, created by Novo Nordisk, keeps the liver from producing too much sugar by slowing digestion, enabling the pancreas to make enough insulin to keep blood sugars at a healthy level.
In a clinical trial, a 14 mg dose of Rybelsus was shown to lower HbA1C levels below seven percent in 77 percent of participants after 26 weeks. Only 31 percent of the patients who were taking a placebo managed to lower their HbA1C levels this much.
As is the case with all drugs, Rybelsus comes with some risks, including nausea, diarrhea, vomiting, decreased appetite, indigestion constipation, and, more rarely, inflammation of the pancreas, vision loss, low blood sugar, and kidney injury. The drug is capable of causing thyroid tumors in some cases. Those who have had a thyroid cancer diagnosis or who have a family history of the disease are not advised to take Rybelsus.
It should also be noted that people with type 1 diabetes or diabetic ketoacidosis should not take this drug. It is only for the treatment of type 2 diabetes in non-emergency situations.