FDA Approves Oral Semaglutide for Patients with Type 2 Diabetes

SEPTEMBER 20, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved semaglutide (Rybelsus) as the first and only oral glucagon-like peptide-1 (GLP-1) analog for adults with type 2 diabetes (T2D).

The approval, granted to Novo Nordisk for 7 mg and 14 mg tablets, indicates semaglutide as a therapy with diet and exercise to improve glucose in T2D patients not achieving their A1C goals with current antidiabetic therapy.

The approval of semaglutide was based on results from 10 clinical trials under the PIONEER program—a series of head-to-head trials comparing the GLP-1 agonist versus sitagliptin, empagliflozin, and liraglutide 1.8 mg in 9543 patients with T2D.

Primary trial results showed the therapy reduced patient A1C, and additionally reduced patient body weight. Common adverse reactions including nausea, abdominal pain, diarrhea, decreased appetite, vomiting, and constipation were reported in ≥5% of patients.

In an interview with MD Magazine® at the American Diabetes Association (ADA) 2019 Scientific Sessions this June, Todd Hobbs, MD, chief medical officer at Novo Nordisk North America, called the oral GLP-1 agonist a therapy which would provide convenience to patients when coupled with diet and exercise.

“You know, an oral therapy that again, patients could benefit from, that hopefully primary care physicians are going to be much more comfortable starting and prescribing and again—that would open up significantly the numbers of patients that could benefit from the therapy next step,” Hobbs said.



At the time of the interview, Hobbs said the company was still working with the FDA to assess the potential cardiovascular outcome benefits associated with—and potentially marketed for—semaglutide.

The FDA is still reviewing Novo Nordisk’s new drug application (NDA) for semaglutide as a therapy indicated for reducing major adverse cardiovascular event (MACE) risk in adults with T2D and established cardiovascular disease—an application submitted to the FDA along with its currently accepted indication earlier this year.

Novo Nordisk anticipates a decision the NDA by early 2020.

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