US FDA approves MannKind’s inhaled insulin for children

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)