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Ultomiris FDA Approval History

Last updated by Judith Stewart, BPharm on May 1, 2022.

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, Myasthenia Gravis

Ultomiris (ravulizumab-cwvz) is a long-acting C5 complement inhibitor used for the treatment of paroxysmal nocturnal hemoglobinuria, hemolytic uremic syndrome, and generalized myasthenia gravis.

  • Ultomiris is indicated 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).
      Limitations of Use: Ultomiris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
    • the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

Development timeline for Ultomiris

Apr 28, 2022Approval Ultomiris Approved in the US for Adults with Generalised Myasthenia Gravis
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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