MannKind's Biologics License Application for Diabetes Treatment Afrezza Accepted by FDA

MT Newswires Live

Oct 13

MannKind (MNKD) said Monday that the US Food and Drug Administration has accepted for review its supplemental biologics license application for Afrezza Inhalation Powder to treat children and adolescents with type 1 or type 2 diabetes.

If approved, Afrezza, approved for adults age 18 and above, would be the first needle-free insulin option for young patients.

The biopharmaceutical company said the application is based on results from a phase 3 study of Afrezza in combination with basal insulin compared with multiple daily injections with basal insulin to treat patients age 4 for through 17.

The supplemental BLA application has been assigned a Prescription Drug User Fee Act target action date of May 29, MannKind said.

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