FDA accepts new pill for type 2 diabetes



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By Steven Reinberg
HealthDay Reporter

FRIDAY, Sept. 20, 2019 (HealthDay News) – A new pill designed to reduce blood sugar levels in people with type 2 diabetes was approved Friday by the US Food and Drug Administration.

Rybelsus (semaglutide) is the first pill of a class of drugs called glucagon-type peptide (GLP-1) approved for use in the United States. Before Rybelsus, the drug had to be injected.

"Prior to this approval, patients did not have an oral GLP-1 option to treat their type 2 diabetes and will now have a new option to treat type 2 diabetes without injection," he said. Dr. Lisa Yanoff in a press release. She is Acting Director of the Division of Metabolism and Endocrinology Products at the FDA's Center for Evaluation and Drug Discovery.

GLP-1 is a hormone that is often found at low levels in people with type 2 diabetes. Rybelsus works by slowing down digestion and preventing the liver from producing too much sugar, which helps the pancreas to produce more insulin.

In clinical trials, Rybelsus significantly reduced blood sugar levels.

After 26 weeks, 77% of patients taking 14 mg of Rybelsus daily saw their HbA1C drop below 7%, compared to 31% of those receiving placebo. HbA1C is a measure of blood glucose.

Rybelsus, manufactured by the pharmaceutical company Novo Nordisk, is not recommended as a first choice for treating diabetes, the FDA said.

The drug has potential risks. This can cause some thyroid tumors. Patients who have had thyroid cancer or a family member who is suffering from it are advised not to take Rybelsus.

Rybelsus is also not intended for people with type 1 diabetes or diabetic ketoacidosis. The label of the drug also warns against pancreatic inflammation, vision loss, hypoglycemia and kidney damage.

The most common side effects are nausea, diarrhea, vomiting, loss of appetite, indigestion and constipation, the FDA said.

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SOURCE: US Food and Drug Administration, press release of September 19, 2019



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