FDA Approves New Novo Nordisk Diabetes Drug

At the end last week, the United States Food and Drug Administration approved a new pill that lowers blood sugar for people who suffer form type 2 diabetes.  This new drug is semaglutide, which will be sold under the brand name Rybelus, by Novo Nordisk.  It is the first medication of its kind in a class called glucagon-like peptide (GLP-1) that have been approved for use in the US.  Drugs like this used to require injection. 

In a news release, acting director for the FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology, Dr. Lisa Yanoff comments, “Before this approval, patients will have a new option for treating type 2 diabetes without injections.”  

If you are not aware, GLP-1 is a hormone that is quite often found to be in low levels among those who have type 2 diabetes.  The drug (Rybelus), then, works by slowing digestion and preventing the liver form overproducing sugar; and that, of course, helps the pancreas to produce a more appropriate amount of insulin.  

So far, clinical trials have showed that the drug definitely lowers blood sugar. 

More specifically, after a period of 26 weeks, 77 percent of patients taking a 14 mg dose of Rybelus, on a daily basis, saw a reduction in HbA1C levels drop below 7 percent, compared against only 31 percent of those taking a placebo.  HbA1C, of course, is a term used in the medical community when measuring blood sugar. 

Now, even though the drug shows great promise it does have risks.  Of course, all drugs carry risks, but this one can actually result in certain thyroid tumors.  Indeed, some patients who have thyroid cancer—or may even have a relative with it—are advised to not take Rybelus.  

In addition, studies indicate that Rybelus is not for people who have type 1 diabetes or have been diagnosed with diabetic ketoacidosis.  The drug label actually warns about associated conditions like pancreatic inflammation, loss of vision, hypglycemia, and even injury to the kidneys.  This is in addition, of course, to the common side effects, which include:  diarrhea, lower appetite, constipation, vomiting, and indigestion.

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