Baqsimi FDA approval : Eli Lilly and Company (Lilly) has secured the US Food and Drug Administration (FDA) approval) for Baqsimi nasal powder for the treatment of severe hypoglycemia in patients with diabetes aged four years and older.
According to the FDA, Baqsimi is the first glucagon therapy approved for the emergency treatment of the condition which can be administered to the patient without an injection.
Severe hypoglycemia results when blood sugar levels of a patient come down to a level where he or she becomes confused or unconscious or faces other symptoms that need assistance from another person for treatment. Usually, severe hypoglycemia affects people with diabetes who use insulin treatment.
Commenting on Baqsimi FDA approval, Janet Woodcock – director of the FDA Center for Drug Evaluation and Research, said: “People who are living with diabetes are at risk of their blood sugar levels falling below the normal range. There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process.
“This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”
Baqsimi is a powder administered into the nose, which has the opposite effect of insulin, which reduces blood sugar levels. It will be available in a single-use dispenser that can be administered to someone having a severe hypoglycemic episode. The glucagon therapy boosts blood sugar levels in the body by triggering the liver to release stored glucose into the bloodstream.
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