New GLP-1 Agonist Approved by FDA: Semaglutide
Mar 27, 2018, 21:28 PM
I learned about the management of type 2 diabetes mellitus in the fall of 2005. At the time, I was a third-year professional pharmacy student and wondered “How will I learn about all of these drugs?” At the time, I learned about metformin, first- and second-generation sulfonylureas, thiazolidinediones, alpha-glucosidase inhibitors, and insulin therapy. For insulin therapy, I think I learned about Novolog, Humalog, Novolin/Humulin R or N, and Lantus.
Now, I teach about the management of type 2 diabetes mellitus for third-year pharmacy students. Every year, I update my lecture and study guide to include more drugs that have been approved by the Food and Drug Administration (FDA) or are very close to approval. In the fall of 2017, I added some information about semaglutide and told the class, “Once I am done lecturing, this medication will be approved.” That was October 20, 2017…and sure enough, semaglutide was approved on December 5, 2017.
It is essential to remember that diabetes management is individualized considering efficacy, tolerance, patient preference and cost for our patients.
Prior to October 2017, there were six available GLP-1 agonists – twice-daily exenatide immediate-release (BYETTA), once-daily lixisenatide (ADLYXIN), once-daily liraglutide (VICTOZA), once-weekly exenatide extended-release (BYDUREON), once-weekly albiglutide (TANZEUM) and once-weekly dulaglutide (TRULICITY). Semaglutide or OZEMPIC is the fourth FDA-approved once-weekly agent in this class of medications. A GLP-1 agonist has multiple mechanisms of action that can be beneficial for a person with type 2 diabetes. As a review, a GLP-1 agonist increases insulin secretion from beta-cells and suppresses glucagon secretion from alpha-cells. In addition, a GLP-1 agonist can slow gastric emptying and promote satiety. Once-weekly GLP-1 agonists can provide reduction in fasting blood glucose levels and promote weight loss; in addition, the risk of nausea is lower than a short-acting GLP-1 agonist but there is a higher risk of injection-site nodules.
Here are the key points regarding semaglutide:
- Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Half-life: Seven days, allowing for once-weekly administration
- Contraindication: Thyroid C-cell tumors among individuals with a personal or family history
- Safety profile: Diarrhea, nausea, vomiting and injection site reactions
- Product availability: Single-patient-use injector pen, to be administered in abdomen, thigh or arm
- Dosing: 0.25 mg once weekly for four weeks, then 0.5 mg once weekly
- Maximum dose: 1 mg once weekly
Compared to other GLP-1 agonists, semaglutide offers several advantages, such as weight loss (greater than other GLP-1 agonists) and head-to-head evidence against dulaglutide (better results compared to this once-weekly GLP-1 agonist). Semaglutide will not be compared to liraglutide, as both products are made by Novo Nordisk. I am very interested in learning about future evidence and use of this product, as it is being studied for obesity management (Phase III trials) and non-alcoholic fatty liver disease (Phase II trials). Cost will remain a big factor, as I expect semaglutide to be priced at a similar cost to other GLP-1 agonists (estimated $250-300 per month). With this new approved agent, there have been other updated GLP-1 agonists, as exenatide extended-release is now available in an autoinjector and albiglutide will not be off the market after July 2018. Overall, it is essential to remember that diabetes management is individualized considering efficacy, tolerance, patient preference and cost for our patients.
So, what do you think of semaglutide? What do you think are the advantages of this product? The disadvantages? Have you already recommended its use in clinical practice?
About the Author
Jennifer Clements received her Doctorate of Pharmacy from Campbell University in 2006 and completed a primary care residency at a Veterans Affairs Medical Center in 2007. She is also a certified diabetes educator and board certified in pharmacotherapy. Currently, she is an Associate Professor of Pharmacy Practice at Presbyterian College School of Pharmacy.