First noninjection GLP-1 receptor agonist approved

The FDA recently approved semaglutide (Rybelsus) oral tablets, the first noninjection glucagon-like peptide-1 (GLP-1) receptor agonist approved in the U.S., according to a Sept. 20 announcement.

The medication is indicated to improve control of blood glucose in adults with type 2 diabetes, along with diet and exercise. Its efficacy and safety were studied in two placebo-controlled trials and several trials that compared it to other GLP-1 injection treatments (including the PIONEER trials, reviewed in ACP Journal Club).

A boxed warning advises clinicians about a potential increased risk of thyroid C-cell tumors and the fact that the drug is not recommended as the first choice of medicine to treat diabetes. It should not be used in patients who have a personal or family history of medullary thyroid carcinoma or in those who have had multiple endocrine neoplasia syndrome type 2. The drug also carries warnings about pancreatitis, diabetic retinopathy, hypoglycemia, acute kidney injury, and hypersensitivity reactions. The most common side effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation, according to the FDA announcement.