UPDATE – 7/25/2018 – Lilly clarifies that they are asking for the FDA and the EMA to approve this drug for both people with both type 1 diabetes and people with type 2 diabetes to use.
Nasal glucagon is going before U.S. and European medical regulators for approval.
Eli Lilly and Company briefly mentioned during an earnings call that the company has submitted to the FDA a New Drug Application for a nasally administered glucagon formulation. The company also announced that it has applied for similar clearance for the nasal glucagon from the European Medicines Agency.
If approved, nasal glucagon has the potential to reshape treatment for severe hypoglycemia for people with diabetes. The current glucagon treatment is injectable and must be mixed before use. Unfortunately, glucagon treatment is often most needed when people with diabetes are incapacitated, and loved ones too often wait for paramedics or hospital staff to treat the low rather than use it. This can delay needed treatment and increase the risk of complications or death.
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News of the FDA submission comes shortly after results were released of two Phase III trials demonstrating that the nasal glucagon was used successfully by caregivers of people with type 1 diabetes to treat hypoglycemia in real world conditions. Previous studies provided evidence that nasal glucagon worked as well as injectable glucagon to treat hypoglycemia.
Lilly first acquired the worldwide rights to nasal glucagon from Locemia Solutions, the company which first developed nasal glucagon, in 2015. DeShong Perry-Smitherman, a global communications manager with Lilly, wrote in an email that the company is committed to bringing nasal glucagon to market as soon as possible.
Curiously, news of the FDA and EMA submissions for nasal glucagon did not make the cut for the initial press release for the earnings call.
We will keep you posted on any decisions made by the FDA and the EMA on nasal glucagon as soon as we hear word.