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 neuromyelitis optica spectrum disorder (NMOSD). Sold as Uplizna. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Inebilizumab-Cdon (sold as Uplizna), first approved Jun 11, 2020, with 2 new uses approved and 0 published complete response letters.
First approved: Jun 11, 2020
Applications: 1
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $121M
Orphan exclusivity until: Jun 11, 2027
First approved in the EU: Apr 25, 2022
First approved in Japan: Mar 23, 2021
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
treatment of myasthenia gravisHorizon Therapeutics Ireland Designated Activity Company (a subsidiary of Amgen Inc.) · designated Jan 2, 2025 · approved Dec 11, 2025
First approved in Japan 9 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
UpliznaA drug with a new indication for the prevention of relapse of IgG4 related disease. · Tanabe Pharma Corporation · Nov 20, 2025 · Review report
Uplizna, new ingredientA drug with a new active ingredient indicated for the prevention of relapse of neuromyelitis optica spectrum disorder (including neuromyelitis optica). · Mitsubishi Tanabe Pharma Corporation · Mar 23, 2021
Clinical Trials
1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all
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
