Eli Lilly's Baqsimi garners FDA approval as first nasally administered glucagon for severe hypoglycaemia

Eli Lilly announced that the FDA approved Baqsimi (glucagon) for the treatment of severe hypoglycaemia in people with diabetes ages four years and above, making the drug the first nasally administered formulation of rescue glucagon authorised in the US. The company noted that the product is expected to be available in pharmacies within one month and will carry a list price of $280.80 for a one-pack and $561.60 for a two-pack.

Baqsimi, which Eli Lilly gained from Locemia Solutions in 2015, is a portable, dry nasal spray form of glucagon, ready to use with no reconstitution or priming required in a single, fixed 3mg dose. The drugmaker said it is in discussions with insurance providers regarding the drug, adding that eligible commercially insured people can pay as little as $25 for up to two devices if they use the savings card.

"Until now, people suffering from a severe hypoglycaemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process," noted 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," Woodcock added.

The approval was supported by studies showing that Baqsimi had comparable efficacy to injectable glucagon in adults, while 100% of paediatric patients given the inhaled therapy met treatment success. Eli Lilly added that results also demonstrated that the common cold with nasal congestion did not impair absorption of Baqsimi.

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