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Ultomiris FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved December 21, 2018)
Brand name: Ultomiris
Generic name: ravulizumab-cwvz
Dosage form: Injection
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria, Hemolytic Uremic Syndrome

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor for:

  • the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)
  • the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

Development Timeline for Ultomiris

Jun  7, 2021Approval  Alexion Announces FDA Approval of Ultomiris (ravulizumab-cwvz) for Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Oct 12, 2020Approval  Alexion Receives FDA Approval for New Advanced Formulation of Ultomiris (ravulizumab-cwvz) with Significantly Reduced Infusion Time
Oct 18, 2019Approval  Alexion Receives FDA Approval for Ultomiris (ravulizumab-cwvz) for Atypical Hemolytic Uremic Syndrome (AHUS)
Dec 21, 2018Approval  FDA Approves Ultomiris (ravulizumab-cwvz) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Jun 19, 2018Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.

Further information

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