Lysosomal Acid Lipase Deficiency

• EMA approval · 2026-03-24
  EMA Authorised: Kanuma (sebelipase alfa) — Alexion Europe SAS

  The EMA authorised Kanuma (sebelipase alfa) for an inborn error of lipid metabolism. It was granted orphan medicine status with accelerated …

• FDA approval · 2024-07-10
  FDA Approved: KANUMA — Supplemental Application (Alexion Pharmaceuticals, Inc.)

  FDA approved a supplemental application for KANUMA (sebelipase alfa) by Alexion Pharmaceuticals, Inc.

• FDA approval · 2021-11-19
  FDA Approved: KANUMA — Supplemental Application (Alexion Pharmaceuticals, Inc.)

  FDA approved a supplemental application for KANUMA (sebelipase alfa) from Alexion Pharmaceuticals, Inc.

• FDA approval · 2015-12-08
  FDA Approved: KANUMA — Original Application (Alexion Pharmaceuticals, Inc.)

  The FDA approved Kanuma (sebelipase alfa) from Alexion Pharmaceuticals as the original approval for the treatment of lysosomal acid lipase d…

• EMA approval · 2015-06-26
  EMA fast-tracks enzyme replacement therapy for lysosomal acid lipase deficiency

  EU regulators have fast-tracked an enzyme replacement therapy for lysosomal acid lipase deficiency, accelerating development and potential a…

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