FDA Approves Baqsimi, First Nasal Glucagon

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FDA Approves First Nasal Glucagon

The U.S. Food and Drug Administration (FDA) has approved Baqsimi, the first nasal glucagon for treatment of severe hypoglycemia (very low blood sugar) in people with diabetes ages 4 and up, manufacturer Eli Lilly has announced.

Baqsimi (image courtesy of Eli Lilly)

Severe hypoglycemia is a medical emergency characterized by changes in mental or physical functioning that can affect people with type 1 or type 2 diabetes. Untreated, it can lead to serious consequences, such as loss of consciousness, seizure, coma or death.

Glucagon is a hormone used to treat severe hypoglycemia that increases blood glucose levels, converting stored glycogen in the liver into glucose. To date, glucagon kits have required dilution of the medicine with a sterile liquid, with the solution delivered by injection. Unlike traditional glucagon, Baqsimi does not require reconstitution or needles. The nasal powder comes in a ready to use, single, fixed 3-milligram dose.

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“Severe hypoglycemia is an unpredictable event for people with diabetes that can happen anytime, anywhere. It’s an experience that can be very stressful and difficult for those helping a person in a low blood sugar emergency,” noted Sherry Martin, MD, Vice President of Lilly Medical Affairs. “The FDA’s approval of Baqsimi may help people prepare for these moments with an innovative product that has the simplicity of nasal administration.”

The medicine is expected to be available in U.S. pharmacies within one month, and Eli Lilly is in discussions with insurance providers to make Baqsimi available to as many people as possible. With use of a savings card, eligible, commercially insured people can pay as little as $25 for up to two Baqsimi devices (which is generally a yearly prescription). Lilly may additionally be able to assist those without commercial insurance via the Lilly Diabetes Solutions Center.

Those with questions or who would like to sign up to receive direct updates about Baqsimi can visit the official Baqsimi website or contact The Lilly Answers Center at (800) LillyRx (545-5979).

Want to learn more about hypoglycemia? Read “Understanding Hypoglycemia,” “Exorcising the Specter of Overnight Hypoglycemia” and “Hypoglycemia Unawareness.”

Diane Fennell

Diane Fennell

Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.

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