Fabry Disease

• EMA approval · 2026-03-31
  EMA Authorised: Elfabrio (pegunigalsidase alfa) — Chiesi Farmaceutici S.p.A

  EMA authorised Elfabrio (pegunigalsidase alfa) from Chiesi Farmaceutici S.p.A for Fabry disease.

• EMA approval · 2025-12-19
  EMA Authorised: Replagal (agalsidase alfa) — Takeda Pharmaceuticals International AG Ireland Branch

  The EMA authorised Replagal (agalsidase alfa) for treatment of Fabry disease, with Takeda Pharmaceuticals International AG Ireland Branch as…

• EMA approval · 2025-08-25
  EMA Authorised: Galafold (migalastat hydrochloride) — Amicus Therapeutics Europe Limited

  The EMA authorised Galafold (migalastat hydrochloride) by Amicus Therapeutics Europe Limited for Fabry disease, with orphan medicine designa…

• FDA approval · 2025-01-17
  FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ELELYSO (taliglucerase alfa) submitted by Pfizer Laboratories Div Pfizer Inc.

• EMA approval · 2024-09-04
  EMA Authorised: Fabrazyme (agalsidase beta) — Sanofi B.V.

  The European Medicines Agency authorised Fabrazyme (agalsidase beta) for Fabry disease, with Sanofi B.V. as the marketing authorization hold…

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• FDA approval · 2024-07-10
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for FABRAZYME (agalsidase beta) by Genzyme Corporation.

• FDA approval · 2024-06-05
  FDA Approved: GALAFOLD — Supplemental Application (Amicus Therapeutics US, LLC)

  The FDA approved a supplemental application for GALAFOLD (migalastat hydrochloride) from Amicus Therapeutics US, LLC. The action updates the…

• FDA approval · 2024-02-06
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for FABRAZYME (agalsidase beta) submitted by Genzyme Corporation. FABRAZYME is an enzyme replace…

• FDA approval · 2023-06-20
  FDA Approved: GALAFOLD — Supplemental Application (Amicus Therapeutics US, LLC)

  The FDA approved a supplemental application for Galafold (migalastat hydrochloride) from Amicus Therapeutics US, LLC. The action pertains to…

• FDA approval · 2023-05-09
  FDA Approved: ELFABRIO — Original Application (Chiesi USA, Inc.)

  The FDA granted approval for ELFABRIO (pegunigalsidase alfa) from Chiesi USA, Inc. as an original enzyme replacement therapy for Fabry disea…

• FDA approval · 2021-12-10
  FDA Approved: GALAFOLD — Supplemental Application (Amicus Therapeutics US, LLC)

  The FDA approved a supplemental application for GALAFOLD (migalastat hydrochloride) to expand its labeling for Fabry disease.

• FDA approval · 2021-03-11
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental Biologics License Application for FABRAZYME (agalsidase beta) from Genzyme Corporation.

• FDA approval · 2019-11-01
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for Fabrazyme (agalsidase beta) from Genzyme Corporation.

• FDA approval · 2018-12-18
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for FABRAZYME (agalsidase beta) from Genzyme Corporation.

• FDA approval · 2018-08-10
  FDA Approved: GALAFOLD — Original Application (Amicus Therapeutics US, LLC)

  FDA approved GALAFOLD (migalastat hydrochloride) under Original Application from Amicus Therapeutics US, LLC for the treatment of Fabry dise…

• FDA approval · 2016-12-20
  FDA Approved: ELELYSO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for ELELYSO (taliglucerase alfa) from Pfizer Laboratories Div Pfizer Inc.

• EMA approval · 2016-04-01
  First oral treatment for Fabry disease recommended for approval in the EU

  The EMA recommended approval for the first oral treatment for Fabry disease in the EU, marking a potential new oral option for patients.

• FDA approval · 2008-12-17
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  The FDA approved a supplemental application for Fabrazyme (agalsidase beta) submitted by Genzyme Corporation. This approval authorizes chang…

• FDA approval · 2006-09-29
  FDA Approved: FABRAZYME — Supplemental Application (Genzyme Corporation)

  FDA approved a supplemental application for FABRAZYME (agalsidase beta) from Genzyme Corporation.