HomeClinical TopicsFDA approves new diabetes treatment

FDA approves new diabetes treatment

Author(s): Lydia L. Kim, Digital Content Editor

In late September 2019, the U.S. Food and Drug Administration (FDA) approved a new oral treatment for type 2 diabetes. Novo Nordisk’s Rybelsus (semaglutide) helps improve adult patients’ blood sugar levels when combined with diet and exercise.

Rybelsus is the first glucagon-like peptide (GLP-1), noninjectable treatment approved in the United States.

Several clinical trials examined Rybelsus’ efficacy in reducing blood sugar in patients with type 2 diabetes: two were placebo-controlled, several compared Rybelsus to other GLP-1 treatments, some examined Rybelsus as a monotherapy, and some in combination with other treatments. Results of the studies in which Rybelsus was examined as a stand-alone therapy revealed “a significant reduction in blood sugar.”

One of the biggest benefits of this new treatment is summarized by Lisa Yanoff, MD, the Director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research: “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…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.”

The treatment does have several box warnings and adverse events, including (but not limited to): pancreas inflammation, retina damage, hypoglycemia, diarrhea, vomiting, and acute kidney injury. Rybelsus should be taken with 4 ounces of water 30 minutes before the patient’s first meal, beverage, or other oral medication.

Please read more about this approval here.





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