During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe hypoglycemia in diabetes patients taking insulin. Lilly acquired worldwide rights to the nasal glucagon powder from Locemia in 2015.
The MAA was submitted under the centralized procedure, according to a company spokesperson who also said that Lilly expects to submit an application in Canada by the end of the year.
Severe hypoglycemia can cause “severe cognitive impairment requiring external assistance for recovery,” according to the American Diabetes Association, and the nasal glucagon, which is delivered via a single use device, is meant to be administered by a caretaker. According to the company, “There is no need for the person with diabetes to inhale or breathe deeply, and nasal glucagon can be used in cases of severe hypoglycemia with nasal congestion.”
Lilly Diabetes Senior Medical Director Thomas Hardy commented, “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. We are in the final stages of development for nasal glucagon and have made excellent progress toward ensuring manufacturing capabilities are in place to distribute nasal glucagon once approved.”
