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 Soliris. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Eculizumab (sold as Soliris), first approved Mar 16, 2007, with 5 new uses approved and 0 published complete response letters.
First approved: Mar 16, 2007
Applications: 1
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $421M
Orphan exclusivity until: Feb 28, 2032
First approved in the EU: Jun 20, 2007
First approved in Japan: Apr 16, 2010
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 37 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
SolirisA drug with a new additional pediatric dosage indicated for the treatment of generalized myasthenia gravis (for use only in patients whose symptoms cannot… · Alexion Pharma GK · Aug 23, 2023
SolirisA drug with a new additional indication for the prevention of relapse of neuromyelitis optica spectrum disorder (including neuromyelitis optica). · Alexion Pharma GK · Nov 22, 2019
SolirisA drug with a new additional indication and a new dosage indicated for the treatment of generalized myasthenia gravis (for use only in patients whose… · Alexion Pharma G.K. · Dec 25, 2017 · Review report
SolirisA drug with a new additional indication and a new dosage for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit… · Alexion Pharma G.K. · Sep 13, 2013
Soliris, new ingredientA drug with a new active ingredient indicated to reduce hemolysis in patients with paroxysmal nocturnal hemoglobinuria. · Alexion Pharma K.K. (currently Alexion Pharma G.K.) · Apr 16, 2010
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
