On July 28, the United States Food and Drug Administration approved Adlyxin (lixisenatide), a daily injectable that has been proven to improve glycemic control in adults with type 2 diabetes.
The FDA approved the drug as a treatment for diabetes. Type 2 diabetes currently affects more than 29 million people around the world. 90% of all diabetes diagnoses in the United States are for type 2 diabetes.
In a groundbreaking study, the drug was seen to improve glycemic control (your blood sugar levels) when used in conjunction with diet and exercise.
How Does Adlyxin Work?
Adlyxin is a glucagon-like peptide-1 (also known as GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels.
Prior to approving the drug, Adlyxin went through 10 clinical trials involving a total of 5,400 patients with type 2 diabetes. Studies evaluated Adlyxin as a standalone therapy and used in combination with other FDA-approved treatments – like metformin, sulfonylureas, pioglitazone, and basal insulin.
Throughout these studies, the use of Adlyxin was seen to improve hemoglobin A1c levels. Hemoglobin A1c is a measurement of blood sugar levels.
In further studies, 6,000 more patients underwent treatment with either Adlyxin or a placebo. These 6,000 patients had type 2 diabetes with a risk of developing atherosclerotic cardiovascular disease. The use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.
Ultimately, based on all of this research, the FDA approved Adlyxin as a treatment for diabetes. It’s not designed for use in people with type 1 diabetes or those with increased ketones in their blood or urine.
How to Use Adlyxin
The FDA recommends using Adlyxin along with a careful diet and exercise routine.
Using Adlyxin involves injecting it into your body once per day. When you do this in conjunction with diet and exercise, it’s proven to improve patients’ blood sugar levels.
Side Effects of Adlyxin
In the FDA’s announcement of Adlyxin, they stated that the drug has been linked to specific side effects, including nausea, vomiting, headache, diarrhea, and dizziness.
Hypoglycemia was also an observed side effect, but only in patients treated with both Adlyxin and other antidiabetic drugs (like basal insulin).
Some patients also experienced hypersensitivity reactions, like anaphylaxis.
Further Studies Required
The FDA has approved Adlyxin for the treatment of type 2 diabetes. However, they still require further studies including:
-Clinical studies to evaluate the dosing, efficacy, and safety in pediatric patients
-A study evaluating the immunogenicity of lixisenatide
Basically, the FDA wants to know how the drug reacts when used in children, and how the immune system responds to the drug.
Who Makes Adlyxin?
Adlyxin is made by a company named Sanofi. Sanofi is a global healthcare company that discovers, develops, and distributes pharmaceuticals.
The company has five global business units, including Diabetes & Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, and Sanofi Pasteur and Merial. Adlyxin was created by Sanofi’s Diabetes & Cardiovascular division.
