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US FDA approves MannKind’s inhaled insulin for children

By Thomson Reuters May 29, 2026 | 11:44 AM

By Sahil Pandey and Sriparna Roy

May 29 (Reuters) – The U.S. Food and Drug Administration has approved expanded use of MannKind’s inhaled rapid-acting insulin in children ​with diabetes, offering patients under 18 years of ‌age a needle-free treatment option, the company said on Friday.

Shares of the company were up 6% in afternoon trading.

The approval broadens treatment options for younger patients who require insulin, often several times ‌a ​day, to manage diabetes, a condition ⁠where the body cannot ⁠properly regulate blood sugar levels.

According to Jennifer Segrist, mother of 15-year-old Taisie Segrist, who was part of MannKind’s research study, her daughter initially needed several injections ​a day, which was traumatizing for a child her age.

But switching to inhaled insulin had been “life changing,” ⁠making her more independent in ⁠managing the condition, Segrist told Reuters.

“It really ​does make a huge difference… diabetes is not such a ​huge weight on her shoulders anymore.”

Unlike conventional insulin, which ‌is injected subcutaneously and could affect adherence especially in children, MannKind’s Afrezza is inhaled through a small device to help control blood sugar levels at mealtimes.

It was ⁠first approved by the FDA for adults in June 2014.

The drug, approved for use in children aged six and above ⁠with Type 1 ‌and Type 2 diabetes, has a rapid ⁠onset and short duration of action, ​more closely ‌mimicking the body’s natural insulin response ​to meals. ⁠The company said eligible patients can access Afrezza for $35 or less a month.

However, the company said Afrezza could cause serious side effects such as sudden lung problems.

(Reporting by Siddhi Mahatole, Sahil Pandey and Sriparna Roy in Bengaluru; Editing ​by Diti Pujara)