FDA Approves BAQSIMI, The First and Only Nasally Administered Glucagon to Treat Severe Hypoglycemia

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The U.S. Food and Drug Administration (FDA) has approved Lilly’s BAQSIMI (glucagon) nasal powder 3 mg for the treatment of severe hypoglycemia in people with diabetes ages four years and above. BAQSIMI is the first and only nasally administered glucagon, and it was designed with severe hypoglycemia rescue in mind.

Severe hypoglycemia is a serious medical condition that constitutes an emergency for people with type 1 and type 2 diabetes. It is characterized by altered mental and/or physical functioning that requires assistance from another person for recovery. If untreated, severe hypoglycemia can lead to serious consequences, such as loss of consciousness, seizure, coma and death.

BAQSIMI is a portable, dry nasal spray form of glucagon, ready to use with no reconstitution or priming required in a single, fixed 3 mg dose. It is absorbed in the nose, so does not require inhalation. BAQSIMI does not need to be refrigerated and can be stored at temperatures up to 86°F/30°C in the shrink-wrapped tube provided.


Acquired by Lilly from Locemia Solutions in 2015, BAQSIMI is a new formulation of rescue glucagon. Dr. Claude Piche, CEO and co-founder of Locemia Solutions, credits co-founder Robert Oringer as the original inspiration behind BAQSIMI. Oringer has two sons diagnosed with type 1 diabetes. 

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Cella Beltramo
Cella Beltramo
1 year ago

Aptar reported that Baqsimi is the first FDA approval of a prescription drug in the Unidose Powder System and Aptar’s first combination of a drug delivery device with a protective active packaging container. It is also the first approval and customer launch combining the technologies of Aptar Pharma and Aptar CSP Technologies, which developed the container that protects and stores the Unidose Powder System. It employs Aptar’s Activ-Polymer technology for ensuring moisture protection throughout shelf life. “We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment… Read more »

J. Kimbrough
J. Kimbrough
2 years ago

Is Medicare going to pay for this? Does anyone know?

Ivan
Ivan
2 years ago

How much does it cost? How long can it be kept on the shelf unused?

Madeleine Mulanix
Madeleine Mulanix
2 years ago
Reply to  Ivan

Probably so expensive that the normal person won’t be able to afford it, just like many diabetes meds.

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