Lilly Files for FDA Approval of Nasal Glucagon


Editor’s Note: Nasal Glucagon BAQSIMI was approved by the FDA and is now available in the United States, as of August 2019.

Eli Lilly and Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and an EU Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for nasal glucagon. If the drug receives approval, it will be the first dry powder nasal spray on market to treat severe hypoglycemia.

Hypoglycemia affects people with type 1 or type 2 diabetes and is the state of low blood sugar that is caused by too much insulin or too little sugar in the body. It is defined as a blood sugar below 3.9 millimoles per liter (mmol/L)70 milligrams per deciliter (mg/dL). Untreated, it may result in seizures, unconsciousness and sometimes death.

Glucagon is a hormone medicine used in emergencies when a person with diabetes cannot take sugar orally to raise blood sugar. Lilly’s current glucagon treatment is a much more invasive injection that has to be assembled by adding liquid to powder in order to dissolve and activate the glucagon mixture.

glucagon diagram

Because glucagon is used in emergency situations to treat a severe episode of hypoglycemia, it ideally would be easier to administer. The nasal glucagon would be just that, less complicated and faster in application.  

The nasal doser fits in the palm of your hand and uses a small plunger on the bottom that when pressed releases the powder glucagon up one of the nostrils. The glucagon is immediately absorbed.

Nasal glucagon was developed by the pharmaceutical company Locemia and was acquired by Lilly in October of 2015. If approved, the new method of glucagon delivery would revolutionize severe hypoglycemia treatment for people managing type 1 or type 2 diabetes.

The pharmaceutical company said, “Lilly is committed to bringing nasal glucagon to market as soon as possible, as we believe a simple, ready-to-use approach to treating severe hypoglycemia via nasal delivery could be an important advance for people with diabetes and their caregivers. It may also expand the community of people who could quickly render aid in a rescue situation.”