Eli Lilly's hypoglycemia treatment wins FDA approval

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[July 25, 2019]  (Reuters) - The U.S. Food and Drug Administration approved Eli Lilly and Co's treatment for severe hypoglycemia, the health regulator said on Wednesday.

Hypoglycemia is a condition in which blood sugar falls to dangerously low levels.

Severe hypoglycemia typically occurs in people with diabetes who are using insulin treatment, the FDA said and noted that the therapy - Baqsimi - is approved to treat the severe form of the condition in patients with diabetes aged four and older.

Baqsimi is a powder that is administered into the nose. It is the first glucagon therapy approved for the emergency treatment of the condition, without using an injection, the agency said.

"This new way to administer glucagon may simplify the process, which can be critical during an episode," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

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"The U.S. list price for a Baqsimi one-pack is $280.80 and $561.60 for a two-pack," the company said in a statement, adding that Baqsimi is expected to be available in U.S. pharmacies within a month.

The FDA said injectable glucagon has been approved for use in the United States for several decades.

(Reporting by Aakash Jagadeesh Babu in Bengaluru, Additional reporting by Maria Ponnezhath; Editing by Bernard Orr and Sherry Jacob-Phillips)

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