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Fiasp: New Rapid-Acting Mealtime Insulin Approved by FDA

Adults with type 1 or type 2 diabetes have a new treatment option available to them following the US Food and Drug Administration’s (FDA) decision to approve Novo Nordisk's rapid-acting mealtime insulin Fiasp (insulin aspart). 

The drug is indicated to improve glycemic control in adults with diabetes and can be dosed just before a meal or within 20 minutes of starting a meal. It is a new formulation of existing product NovoLog, with the inclusion of niacinamide (vitamin B3) to increase the speed of initial insulin absorption. It is available in a pre-filled single use 3ml FlexTouch pen and as a 10 ml vial. 

Fiasp was approved following a phase IIIa clinical trial involving more than 2,000 adults with type 1 and type 2 diabetes, which demonstrated a reduction in blood sugar levels in the A1C blood tests. The man-made insulin is not indicated for pediatric use and should not be used by patients having an episode of hypoglycemia or by anyone with an allergy to insulin aspart. 

Novo Nordisk's diabetes medication is not the first fast-acting mealtime insulin to gain FDA approval in the United States. Other products already available in pharmacies are Humalog and Novolog. In a Novo Nordisk press release, Bruce Bode, MD, president of Atlanta Diabetes Associates and associate professor at Emory University School of Medicine commented: “The intention of rapid-acting insulin therapy is to mimic, as much as possible, the natural physiological insulin response that occurs after meals, a process that is important for optimal A1C management.”  

More than 30 million people in the United States have diabetes, according to the latest National Diabetes Statistics Report 2017, compiled by the Centers for Disease Control and Prevention. The study revealed 23 million people have already been diagnosed with the condition, but that up to 7.2 million Americans are as yet undiagnosed. The most common form is type 2 diabetes, which accounts for more than 90 percent of diabetes cases. 

Common adverse reactions to Fiasp

Common adverse reactions experienced by patients taking Fiasp included nasopharyngitis, upper respiratory tract infection, nausea, diarrhea and back pain. Other possible side effects include skin problems such as eczema, reactions at the injection site, skin thickening or pits at the injection site, and weight gain. 

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