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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