Neuromyelitis Optica Spectrum Disorder

• FDA approval · 2026-03-26
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen.

• EMA approval · 2026-02-16
  EMA Authorised: Enspryng (satralizumab) — Roche Registration GmbH

  The EU authorised Enspryng (satralizumab) by Roche Registration GmbH for neuromyelitis optica spectrum disorder (orphan medicine).

• FDA approval · 2025-11-24
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, a biosimilar to eculizumab.

• FDA approval · 2025-09-02
  FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for EPYSQLI (eculizumab-aagh) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2025-03-12
  FDA Approved: EPYSQLI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's supplemental application for EPYSQLI (eculizumab-aagh), a biosimilar to eculizumab.

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• FDA approval · 2024-10-23
  FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, updating its labeling and indications for this eculizuma…

• FDA approval · 2024-09-19
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals, resulting in updated labeling that ma…

• FDA approval · 2024-05-28
  FDA Approved: BKEMV — Original Application (Amgen Inc)

  FDA approved BKEMV (eculizumab-aeeB), a biosimilar to eculizumab, developed by Amgen. The approval covers the same indications as the refere…

• FDA approval · 2022-09-14
  FDA Approved: ENSPRYNG — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ENSPRYNG (satralizumab) submitted by Genentech, Inc.

• FDA approval · 2021-05-03
  FDA Approved: ENSPRYNG — Supplemental Application (Genentech, Inc.)

  The FDA approved a supplemental application for ENSPRYNG (satralizumab) from Genentech, potentially updating its labeling or expanding its i…

• FDA approval · 2020-08-14
  FDA Approved: ENSPRYNG — Original Application (Genentech, Inc.)

  The FDA approved ENSPRYNG (satralizumab) from Genentech as the original application for the treatment of neuromyelitis optica spectrum disor…

• FDA approval · 2020-06-11
  FDA Approved: UPLIZNA — Original Application (Horizon Therapeutics USA, Inc.)

  FDA approved UPLIZNA (inebilizumab) in an original application for the treatment of neuromyelitis optica spectrum disorder.

• FDA approval · 2019-06-27
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  The FDA approved a supplemental application for SOLIRIS (eculizumab) filed by Alexion Pharmaceuticals Inc., updating labeling to reflect the…

• FDA approval · 2012-12-21
  FDA Approved: SOLIRIS — Supplemental Application (Alexion Pharmaceuticals Inc.)

  FDA approved a supplemental application for SOLIRIS (eculizumab) submitted by Alexion Pharmaceuticals, resulting in changes to the product l…