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

MT Newswires Live
2025/10/13

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.

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10