GLP-1 Agonist in a Pill: FDA Approves Rybelsus – “Oral Sema”

By Emily Fitts, Jimmy McDermott, Kelly Close, and Martin Kurian

An oral (pill) version of Ozempic, Rybelsus, becomes the first GLP-1 agonist pill for type 2 diabetes

In highly anticipated news, Novo Nordisk announced that the FDA has approved the first ever oral (pill) GLP-1 agonist for type 2 diabetes. Rybelsus (what was called oral semaglutide in clinical trials) is a pill version of Ozempic, a GLP-1 agonist that is delivered as a once-weekly injection for type 2 diabetes.

The approval brings more options for people with type 2 diabetes to access the significant benefits of GLP-1 agonists, namely lowering A1C and prompting weight loss. In addition, all the data from clinical trials shows that both Rybelsus (oral) and Ozempic (injectable) semaglutide can benefit heart health: reducing the risk significantly for heart attack, stroke, and heart-related death. This is important given that people with type 2 diabetes are at substantially higher risk of heart disease than those without diabetes. Click here to learn more about the benefits of Rybelsus.

Rybelsus will be available before the end of 2019, though there are no details yet on how much it will cost.  Novo Nordisk said today that a savings card program will be available as soon as Rybelsus becomes available. The program will “keep out-of-pocket costs down to as little as $10/month” for eligible, commercially insured people. These eligibility requirements are not yet known; traditionally those insured by the government are not allowed to join these programs, and we fervently hope Medicare and Medicaid will move forward to approve easier-to-use therapies for the people with diabetes on their programs. 

Notably, the FDA itself put out a press release today about this approval – this is highly unusual and is a sign of its positive significance. The FDA notes that earlier use of GLP-1 therapies is crucial to improving care, and emphasizes the importance of making it easier for people with diabetes to start on GLP-1 treatment. Getting the attention of healthcare providers is such a crucial goal for the field – the average primary care doctor sees 50 patients each week, and this should be a great opportunity for them to teach people about an important treatment option. The European Society for Cardiology recently recommended earlier use of GLP-1; the Rybelsus approval should provide an excellent opportunity to move forward on the new recommendations.

If you have type 2 diabetes and would like more information on GLP-1 agonists to share with your doctor or diabetes specialist (the new term for CDE or diabetes educator), please click here.

diaTribe has many friends who are healthcare providers – click here for fascinating quotes from the experts in response to the Rybelsus approval. Said Dr. John Buse, University of North Carolina, diaTribe Advisory Board member:  “I do think this is a great day for people with diabetes. I do hope that primary care providers whose practice and staffing have difficulty supporting injected therapies will avail themselves of this opportunity.  That is the real opportunity afforded by Rybelsus.” See what other doctors and diabetes specialists had to say and ask yours to write us here.