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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.