Lilly’s Baqsimi nasal powder gains FDA approval after proving non-inferior to injection

pharmafile | July 25, 2019 | News story | Sales and Marketing Baqsimi, Eli Lilly, FDA, US, diabetes, pharma 

Eli Lilly has been awarded approval from the FDA for its Baqsimi nasal powder in the treatment of severe hypoglycaemia, it has emerged, marking the authorisation of the first glucagon therapy in this indication in the US that can be administered without an injection.

Differing from the traditional injectable glucagon treatments which have been approved for decades, the therapy takes the form of a powder which is administered nasally via a single-use dispenser. It is designed to combat the confusion of lapse into unconsciousness that patients can suffer when their blood sugar falls to harmful levels.

Evidence submitted in support of the application demonstrated over two studies, comprising 83 and 70 participants each, that a single dose of Baqsimi “adequately increased blood sugar levels” compared to a single dose of glucagon injection. The drug performed similarly in another study of 48 paediatric patients.

“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,” commented Dr Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. “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.”

Matt Fellows

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