Eli Lilly submitted a new drug application (NDA) to the FDA for a nasal glucagon, an investigational product, for the treatment of severe hypoglycemia in adults and pediatric patients with type 1 and type 2 diabetes.
The announcement was made briefly during an earnings call. The company also announced it submitted a European Union marketing authorization application for nasal glucagon to the European Medicines Agency.
If approved, nasal glucagon could be the first nasal dry powder spray rescue treatment for low blood glucose emergencies in people with diabetes.
“The submissions put us one step closer to bringing this innovative rescue medicine to the diabetes community and filling an important need in the treatment of severe hypoglycemia,” Thomas Hardy, senior medical director, Lilly Diabetes, told Endocrine Today.
The current glucagon treatment is injectable takes several steps before it can be used, which can be cumbersome for someone with severe hypoglycemia to administer themselves.
If approved, nasal delivery of glucagon may be an important advancement for those people in a rescue situation.