On July 24th, the FDA announced that it granted approval to the first-ever non-injectable emergency glucagon. The glucagon powder, which would be administered nasally, is being marketed by Eli Lilly and Company under the brand name of Baqsimi. The treatment is approved for use for people with diabetes, ages four and up.
The long road to FDA approval
The approval marks the end of a decade-long journey to bring nasally administered glucagon to market. Locemia Solutions, a Montreal-based pharmaceutical company, did the early groundwork to develop this novel treatment for severe hypoglycemia. This included two clinical trials, conducted with the help of T1D Exchange researchers and other scientists, to provide data to show that nasal glucagon was safe and effective for treating low blood sugars.
The company then sold the worldwide marketing rights of its nasal glucagon in 2015 to Lilly, which conducted further trials, including studies to show that the glucagon was easy to use and effective in real-world conditions. Lilly submitted the glucagon for approval to the FDA and European health regulators in July 2018.
The European Medicines Agency has not yet made a decision on the novel glucagon treatment.
According to a Close Concerns report, the list price for Baqsimi likely will be the same as the price set by Lilly for its injectable glucagon – $280.80 for a one-pack. The next step for Lilly will be to ensure that there is insurance coverage for the product.
According to DiabetesMine, Baqsimi will be available in U.S. pharmacies within the next month.
Why nasal glucagon is important
The commercial release of a nasal glucagon powder could reshape how severe hypoglycemia is treated. The current glucagons on the market must be mixed before being injected. Diabetes researchers have long known that many people opt not to give this injection to unconscious or incapacitated individuals and instead wait for medical help to arrive. This delay in treatment of severe hypoglycemia can increase the risks of severe complications, hospitalization, and even death, studies show.
Making matters more complex, T1D Exchange data shows that many with type 1 diabetes do not have a current glucagon prescription and some of those who had received an emergency glucagon injection experienced problems with the process. If nasal glucagon proves to be easier to use than the current injectable glucagons on the market, it has the potential to improve outcomes from hypoglycemia, and it might even save lives.