Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats paroxysmal nocturnal hemoglobinuria (PNH). Sold as Ultomiris. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ravulizumab-Cwvz (sold as Ultomiris), first approved Dec 21, 2018, with 7 new uses approved and 0 published complete response letters.
First approved: Dec 21, 2018
Applications: 1
New uses approved: 7
Complete response letters: 0
Medicare spending, 2025: $1.04B
Orphan exclusivity until: Jun 7, 2028
First approved in the EU: Jul 2, 2019
First approved in Japan: Jun 18, 2019
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 6 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
UltomirisDrugs with a new indication for the prevention of relapse of neuromyelitis optica spectrum disorder (including neuromyelitis optica). · Alexion Pharma GK · May 25, 2023
UltomirisDrugs with a new indication for the treatment of generalized myasthenia gravis (for use only in patients whose symptoms cannot be sufficiently controlled… · Alexion Pharma GK · Aug 24, 2022
UltomirisA drug with a new indication and a new dosage for the treatment of atypical hemolytic uremic syndrome (aHUS). · Alexion Pharma GK · Sep 25, 2020
Ultomiris, new ingredientA drug with a new active ingredient indicated for the treatment of paroxysmal nocturnal hemoglobinuria. · Alexion Pharma G.K. · Jun 18, 2019
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
