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 relapsing forms of multiple sclerosis (MS). Sold as Arzerra, Kesimpta. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ofatumumab (sold as Arzerra, Kesimpta), first approved Oct 26, 2009, with 4 new uses approved and 0 published complete response letters.
First approved: Oct 26, 2009
Applications: 1
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $865M
First approved in the EU: Apr 19, 2010
First approved in Japan: Mar 25, 2013
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 41 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Kesimpta, new approvalA drug with a new route of administration and new indications for the prevention of relapse and for delaying the accumulation of physical disability in… · Novartis Pharma K.K. · Mar 23, 2021
Arzerra, new ingredientDrugs with a new active ingredient indicated for the treatment of relapsed or refractory CD20- positive chronic lymphocytic leukemia. · GlaxoSmithKline K.K. · Mar 25, 2013
Clinical Trials
38 open or ongoing studies name 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
Novartis