A new pill to lower blood sugar for people with type 2 diabetes was approved by the U.S. Food and Drug Administration.
The drug, Rybelsus, with the active ingredient semaglutide, is the first pill in a class of drugs called glucagon-like peptide, GLP-1, approved for use in the United States. Before Rybelsus, the drug had to be injected.
"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 in an agency news release Friday. She is acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.
The drug is made by the pharmaceutical company Novo Nordisk,
Novo produces the daily injectable GLP-1 Victoza. Others in the class include the daily shot Adlyxin from Sanofi and Lilly's weekly injection Trulicity. Glucose-lowering pills in other classes include Januvia and Jardiance.
GLP-1 is a hormone often found in low levels in people with type 2 diabetes. Rybelsus acts by slowing digestion and preventing the liver from making too much sugar, which helps the pancreas produce more insulin.
In clinical trials, Rybelsus significantly lowered blood sugar.
After 26 weeks, 77 percent of patients taking 14 mg of Rybelsus daily saw their HbA1C drop below 7 percent compared with 31 percent among those receiving a placebo. HbA1C is a measure of blood sugar.
Rybelsus is not recommended as the first choice for treating diabetes, the FDA said.
The drug has potential risks. It may cause certain thyroid tumors. Patients who have had thyroid cancer or have a relative who has had it are advised not to take Rybelsus.
Rybelsus is also not for people with type 1 diabetes or diabetic ketoacidosis. The drug label also warns about inflammation of the pancreas, vision loss, low blood sugar and kidney injury.
The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation, the FDA noted.
For more on type 2 diabetes, see the American Diabetes Association.
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