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Treats paroxysmal nocturnal hemoglobinuria (PNH). Sold as Bkemv. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Eculizumab-Aeeb (sold as Bkemv), first approved May 28, 2024, with 0 new uses approved and 0 published complete response letters.
First approved: May 28, 2024
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.7M
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 169 months before 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
Program
Updated
BKEMV REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Jun 29, 2026
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
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
