FDA Delays Decision on Eli Lilly’s Nasal Glucagon

FDA Delays Decision on Eli Lilly’s Nasal Glucagon

-Shahd Husein

Eli Lilly and Company’s hopes of bringing nasal glucagon to market may take longer than initially expected.

At a recent earnings call on April 30th, Lilly announced that the U.S. Food and Drug Administration (FDA) has delayed their decision on the company’s New Drug Application for a nasal glucagon, an alternative to injectable glucagon. The delay, according to Lilly, could take up to three months.

The submission to both the FDA and the European Medicines Agency (EMA) occurred early last year after the completion of two Phase III studies, a jointly funded effort by Eli Lilly and Locemia Solutions, the company that initially developed nasal glucagon. The study was completed just three years after Lilly announced that they had acquired worldwide rights to nasal glucagon from Locemia Solutions.

The FDA did not comment for this story on their decision to delay their decision on the novel glucagon treatment.

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For the most recent study, researchers set out to understand if caregivers could use nasal glucagon to treat moderate to severe lows. Results from the study determined that caregivers of individuals living with diabetes felt comfortable nasally administering the drug, whereas loved ones typically felt discomfort with the current form of glucagon treatment, which includes a multi-step process of mixing and injecting the solution.

Glucagon is a powerful, life-saving drug that is used to counter incidences of moderate to severe hypoglycemia, or low blood glucose levels. With Lilly’s submission, the company hopes to bring an alternative solution to market, diversifying the ways in which to administer treatment, and giving individuals with diabetes and caregivers an easier option in seemingly stressful situations.

Despite delays, Lilly is hopeful. “We remain confident in nasal glucagon’s submission package and look forward to FDA action in the coming months,” said Dave Ricks, CEO of Eli Lilly.

We will continue to keep you posted on any decisions on nasal glucagon from the FDA and the EMA.

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