Mucopolysaccharidosis Type Ii

• EMA approval · 2025-04-16
  EMA Authorised: Elaprase (idursulfase) — Takeda Pharmaceuticals International AG Ireland Branch

  The European Medicines Agency authorised Elaprase (idursulfase) for treatment of mucopolysaccharidosis type II (Hunter syndrome), with Taked…

• FDA approval · 2011-03-08
  FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for Elaprase (idursulfase) from Takeda Pharmaceuticals America, Inc., reflecting a label or indi…

• FDA approval · 2010-11-29
  FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ELAPRASE (idursulfase) from Takeda Pharmaceuticals America, Inc.

• FDA approval · 2007-10-24
  FDA Approved: ELAPRASE — Supplemental Application (Takeda Pharmaceuticals America, Inc.)

  The FDA approved a supplemental application for ELAPRASE (idursulfase) from Takeda Pharmaceuticals America, Inc. The approval updates the pr…

• FDA approval · 2006-07-24
  FDA Approved: ELAPRASE — Original Application (Takeda Pharmaceuticals America, Inc.)

  FDA approval of ELAPRASE (idursulfase) under the original application for the treatment of mucopolysaccharidosis type II (Hunter syndrome) b…

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• FDA approval ·
  FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome

  FDA approved Avlayah (tividenofusp alfa-eknm) to treat neurologic manifestations in individuals with Hunter syndrome (MPS II).