First and Only Nasally Administered Glucagon Approved by FDA

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By : dLife Editors

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’s BAQSIMI™ (glucagon) nasal powder 3 mg for the treatment of severe hypoglycemia in people with diabetes ages four years and above.

Severe hypoglycemia (very low blood sugar) is a serious medical condition that constitutes an emergency for people with Type 1 and Type 2 diabetes.

BAQSIMI is the first and only nasally administered glucagon, and it was designed with severe hypoglycemia rescue in mind.

It is compact, portable and ready to use (no reconstitution required) in a single, fixed, 3 mg dose.

BAQSIMI is contraindicated in patients with pheochromocytoma, insulinoma, and known hypersensitivity to glucagon or to any of the excipients in BAQSIMI.

Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

“Severe hypoglycemia is an unpredictable event for people with diabetes that can happen anytime, anywhere,” said Dr. Sherry Martin, vice president of Lilly Medical Affairs. “It’s an experience that can be very stressful and difficult for those helping a person in a low blood sugar emergency.”

Martin says the FDA’s approval of BAQSIMI may help people prepare for these moments with an innovative product that has the simplicity of nasal administration.

Lilly is in discussions with insurance providers to make BAQSIMI available to as many people as possible. Eligible commercially insured people with diabetes can pay as little as $25 for up to two BAQSIMI devices (1 two-pack or 2 one-packs) if they use the savings card.

This prescription is generally filled on an annual basis.

Lilly may also be able to help people who don’t have commercial insurance coverage with options found through the Lilly Diabetes Solutions Center when BAQSIMI is available in U.S. pharmacies. The U.S. list price for a BAQSIMI one-pack is $280.80 and for a two-pack is $561.60.

People can sign up for direct updates on BAQSIMI availability, patient and caregiver resources, and affordability options at BAQSIMI.com.

BAQSIMI is expected to be stocked in retail pharmacies within one month.

Patients and healthcare professionals with questions about BAQSIMI can visit www.BAQSIMI.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

Source:

  1. Eli Lilly and Company. (2019, July 24). BAQSIMI™ (glucagon) Nasal Powder 3 mg, the First and Only Nasally Administered Glucagon to Treat Severe Hypoglycemia in Adults and Children with Diabetes Ages Four Years and Older, Approved by FDA. PR Newswire. Retrieved July 25, 2019, from https://www.prnewswire.com/news-releases/baqsimi-glucagon-nasal-powder-3-mg-the-first-and-only-nasally-administered-glucagon-to-treat-severe-hypoglycemia-in-adults-and-children-with-diabetes-ages-four-years-and-older-approved-by-fda-300890782.html