What Is Awiqli, and Why Does It Matter?
Awiqli (insulin icodec-abae) is a once-weekly long-acting basal insulin injection approved by the FDA for adults with type 2 diabetes. It helps lower blood sugar levels when used along with a healthy diet and regular exercise. It is taken as a subcutaneous (under-the-skin) shot with a prefilled FlexTouch pen on the same day every week.
Type 2 diabetes is a condition in which the body has trouble controlling blood sugar levels. If it isn't well managed, it can lead to serious complications like heart disease, kidney damage, nerve problems, and vision loss. Many people need insulin to control their diabetes, which often means giving themselves daily injections to keep their blood sugar in a healthy range.
Awiqli is the only long-acting man-made insulin (U-700) in the U.S. that is designed to last an entire week. Its active ingredient, insulin icodec-abae, loosely attaches to a blood protein called albumin, forming a reservoir that slowly and steadily releases insulin into the bloodstream. This lowers blood sugar levels in the same way as human insulin. Because of this slow, steady release, Awiqli provides a consistent dose of insulin icodec-abae and maintains a stable blood sugar-lowering effect throughout the week.
This approval matters because this medicine reduces the number of basal insulin shots from seven to one per week, offering a more convenient option that can be tailored to individual needs and routines.
Why Was It Approved?
The FDA based its decision on clinical studies that compared once‑weekly Awiqli with daily basal insulin and showed that once-weekly Awiqli was effective in lowering levels of A1c (a blood marker that shows your average blood sugar levels over time) in about 2,680 adults with uncontrolled type 2 diabetes who used Awiqli along with oral or injectable diabetes medicines or together with mealtime insulin.
The safety profile for Awiqli looks like that of other long-acting basal insulins. The most common side effect is low blood sugar levels (hypoglycemia). Other common effects included reactions where the needle went in; skin thickening or pits where the needle went in (lipodystrophy); itching, rash, or swelling in the legs or feet (peripheral edema); and weight gain. Serious risks include severe allergic reactions and low potassium levels in the blood (hypokalemia) and heart failure in some people if taken with medicines called thiazolidinediones (TZDs). Awiqli has not been shown to be safe or effective in children or teens.
What Do I Need to Know?
Use Awiqli exactly as your health care provider prescribes. Give yourself a once-weekly subcutaneous shot in your thigh, upper arm, or belly area on the same day every week. Rotate spots within the chosen area each time, and avoid sore, bruised, scaly, thick, scarred, or otherwise damaged skin. Check that the insulin looks clear and colorless before you inject. Do not mix or dilute Awiqli, do not inject it into a vein or muscle, and do not use it in an insulin pump. Store unused pens in the refrigerator, do not freeze them, and keep the cap on when they're not in use.
Use a new needle for every dose, and never share your pen or needles. Do not draw insulin out of the pen with a syringe. Take extra care when dialing your dose because dosing for this medicine is not the same as for other injectable diabetes medicines. Do not change or convert the amount of your dose. The dose counter always shows the exact number of units you are taking. If you miss a dose, take it as soon as you can within four days. If more than four days have gone by, skip the missed dose and take the next one on your usual day.
Do not change or switch to a different type of insulin without consulting your health care provider, as any changes in your insulin medication may also require changing the amount of your dose and the right time to take it.
Before starting Awiqli, tell your health care provider about all your health conditions, especially if you have liver or kidney problems or heart issues (including heart failure) or if you are pregnant, planning to become pregnant, or breastfeeding. Avoid driving or using heavy machinery until you know how this medicine affects you. Avoid alcohol and alcohol-containing products.
Inform your health care provider about all the medicines you take, including prescription medicines, over-the-counter products, vitamins, and herbal supplements, particularly medications called TZDs (thiazolidinediones), which can affect heart health when used with Awiqli. Many medicines can increase or lower the effect of insulin. Your health care provider may change your dose and ask you to check your blood sugar levels more often when your medicines change.
Be sure to discuss hypoglycemia and how to recognize and manage it before you begin treatment. Do not use Awiqli during an episode of hypoglycemia. Your health care provider may change your insulin dose if you change your diet or your physical activity or exercise levels; if you are ill or overstressed; or if you gain or lose weight. Avoid using this medicine if you are allergic to it or to any of the ingredients in it.
Call your health care provider right away if you notice any signs and symptoms of low blood sugar such as dizziness or light-headedness, blurred vision, anxiety, crankiness or mood changes, confusion, a fast heartbeat, or heavy sweating; signs of a severe allergic reaction such as a widespread rash or trouble breathing; or any new or worsening symptoms of heart failure such as shortness of breath, swelling in your ankles or feet, sudden weight gain, or unusual tiredness.
Awiqli is expected to be available across the U.S. in the coming months.