LEMTRADA
Lemtrada (alemtuzumab) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis in adults. The therapy is approved for both relapsing-remitting disease and active secondary progressive disease. Because of its safety profile, use is typically reserved for patients who have had an inadequate response to two or more other drugs indicated for multiple sclerosis. The medication is not recommended for use in patients with clinically isolated syndrome.
How LEMTRADA Works
Alemtuzumab binds to CD52, a cell surface antigen present on T and B lymphocytes, natural killer cells, monocytes, and macrophages. Although the precise therapeutic mechanism is unknown, binding to these lymphocytes results in antibody-dependent cellular cytolysis and complement-mediated lysis. These processes lead to the destruction of the targeted immune cells. This cytolytic action is presumed to be the basis for the drug's effect in treating multiple sclerosis.
Details
- Status
- Prescription
- First Approved
- 2001-05-07
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LEMTRADA Approval History
What LEMTRADA Treats
1 indicationsLEMTRADA is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
LEMTRADA Boxed Warning
AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA [see Warnings and Precautions (5.1) ] . LEMTRADA causes serious and life-threateni...
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last dose of LEMTRADA [see Warnings and Precautions (5.1) ] . LEMTRADA causes serious and life-threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period [see Warnings and Precautions (5.2) ] . Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur [see Warnings and Precautions (5.3) ]. LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams [see Warnings and Precautions (5.4) ] . Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program [see Warnings and Precautions (5.5) ] . WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES See full prescribing information for complete boxed warning. LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell co
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LEMTRADA FDA Label Details
ProIndications & Usage
FDA Label (PDF)LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS [see Warnings and Precautions ] . LEMTRADA is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressiv...
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.