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Kanuma Approval History

  • FDA approved: Yes (First approved December 8th, 2015)
  • Brand name: Kanuma
  • Generic name: sebelipase alfa
  • Dosage form: Injection
  • Company: Alexion Pharmaceuticals, Inc.
  • Treatment for: Lysosomal Acid Lipase Deficiency

Kanuma (sebelipase alfa) is an enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency (LAL-D).

Development History and FDA Approval Process for Kanuma

DateArticle
Dec  8, 2015Approval FDA Approves Kanuma (sebelipase alfa) for Lysosomal Acid Lipase Deficiency
Sep  6, 2015Alexion Receives Notification of PDUFA Date Extension for Kanuma (sebelipase alfa)
May 21, 2013Synageva's Sebelipase Alfa Receives Breakthrough Therapy Designation

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