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 B-cell chronic lymphocytic leukemia (B-CLL). Sold as Campath, Lemtrada. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Alemtuzumab (sold as Campath, Lemtrada), first approved May 7, 2001, with 3 new uses approved and 0 published complete response letters.
First approved: May 7, 2001
Applications: 1
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $1.6M
First approved in the EU: Jul 6, 2001
First approved in Japan: Sep 26, 2014
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 161 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
MabCampathA drug with a new indication and a new dosage for a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation. · Sanofi K.K. · Dec 25, 2020
MabCampath, new ingredientA drug with a new active ingredient indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia. · Sanofi K.K. · Sep 26, 2014
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
Lemtrada REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled
Mar 27, 2026
Clinical Trials
59 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
