Eli Lilly Receives FDA Approval For First Nasally-Administered Hypoglycemia Treatment

The United States Food and Drug Administration has, this week, approved the new Eli Lilly and Company drug for treating severe hypoglycemia in diabetic patients of at least four years of age.  The new treatment is Baqismi (glucagon), which is a 3mg dose of nasal powder, the first—and only—nasally-dosed glucagon. This severe blood sugar drop intervention was previously only available as a complicated injection system. 

Eli Lilly boasts that this new Baqsimi systsem is compact and portable and, most importantly, ready to use in a moment’s notice. This is crucial to hypoglycemia patients as it is an emergency situation in both type 1 and type 2 diabetes patients. If left untreated, it hypoglycemia can lead to very serious consequences, including loss of consciousness, seizures, coma, and even death. 

Lilly Medical Affairs vice president Sherry Martin advises, “Severe hypoglycemia is an unpredictable event for people with diabetes that can happen anytime, anywhere,.  It’s an experience that can be very stressful and difficult for those helping a person in a low blood sugar emergency.”

That in mind, Martin celebrates the FDA’s approval of Baqsimi as a means for helping patients better prepare for unexpected—and often dire—hypoglycemic episodes.  And this all starts and stops with the innovative new dosing method.  The traditional method for administering diabetic interventions was through an injection of glucagon that stimulates the liver to release stored glucose and lower blood sugar levels.  This has been the norm for several decades. 

FDA Center for Drug Evaluation and Research director Janet Woodcock, then, also celebrates this new method as a far easier and more accessible intervention.  She says, “This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or maybe having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”