New Diabetes Medication Gets Green Light

FDA approves Rybelsus (semaglutide) to treat type 2 diabetes

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new diabetes medication.

This new approval is found under the names Rybelsus (brand name) and semaglutide (active ingredient). The FDA approved semaglutide to treat adults with type 2 diabetes in combination with diet and exercise.

This new drug is available in tablet form and is to be taken once a day. It is to be taken at least 30 minutes before you consume any food, beverage or other medication for the day. Rybelsus needs to be taken with no more than 4 ounces of plain water.

Because it does not need to be injected like other diabetes drugs, this new approval offers those with diabetes a new treatment option. Semaglutide is the first in its class of medications (GLP-1 drugs) that does not need to be injected.

“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,” said Dr. Lisa Yanoff, acting director of the FDA's Division of Metabolism and Endocrinology Products, in a press release.

Common side effects of semaglutide may include nausea, diarrhea, vomiting, decreased appetite, indigestion (that can lead to feeling full, burping and discomfort) and constipation.

This medication can slow digestion. Speak with your health care provider about all of the medications you are taking before starting this medication.

Rybelsus comes with a boxed warning regarding an increased risk of thyroid c-cell tumors.

Semaglutide is not for those with type 1 diabetes or diabetic ketoacidosis. It is not recommended as the first choice when treating diabetes.

Serious side effects may include inflammation of the pancreas, damage to the retina, low blood sugar and acute kidney injury.

The FDA granted approval of this medication to Novo Nordisk.

Written by Anyssa Garza, PharmD, BCMAS