How it works: Resetting the immune system →

Lemtrada

EU: Approved in the EU since 2013US: FDA approved 2001

FDA dates refer to the first approval of the product's licence. For alemtuzumab and ofatumumab this was an earlier cancer approval.

Molecule type
Antibody
Mechanism (ChEMBL)
CAMPATH-1 antigen inhibitor
Targets
CAMPATH-1 antigen
Availability
Authorised in all EU and EEA countries. Reimbursement is decided by each country.

Approvals

  • USCampath|Lemtrada · Approved2001-05-07 Source
  • EU/EEALemtrada · Authorised2013-09-12 Source

Safety communications

  • EMA referral (safety) · 2019-04-11

    Lemtrada Source

Most-reported side effects (FDA reports)

Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.

19,415 reports in total, 16,715 marked serious.

  • Headache1,897
  • Fatigue1,870
  • Pyrexia1,791
  • Off label use1,678
  • Rash1,197
  • Nausea1,188
  • Drug ineffective1,022
  • Dyspnoea992
  • Asthenia942
  • Multiple sclerosis relapse911

Trials

Key trials

Large trials with a reported result on their main goal.

  • CARE-MS II

    Completed · Phase 3 · Relapsing MS · Main goal met

  • CARE-MS I

    Completed · Phase 3 · Relapsing MS · Main goal met

Running now

  • Alemtuzumab

    Running, not recruiting · Relapsing MS · ongoing

  • DELIVER-MS

    Running, not recruiting · Phase 4 · Relapsing MS · ongoing

Other trials (27)

Completed small trials, dose-finding studies and trials in other diseases.

  • Alemtuzumab

    Completed · Relapsing MS · no_result_found

  • SUPPRESS

    Completed · Phase 4 · Relapsing MS · results_posted_no_test

  • LemKids

    Terminated · Phase 3 · Relapsing MS · stopped_other

  • Alemtuzumab

    Terminated · Relapsing MS · stopped_other

  • Alemtuzumab

    Completed · MS (type not specified) · result_in_paper_unread

  • ProgramMS

    Status unknown · MS (type not specified) · result_in_paper_unread

  • Alemtuzumab

    Status unknown · Relapsing MS · no_result_found

  • Alemtuzumab

    Completed · MS (type not specified) · no_result_found

  • LemCourse

    Completed · Phase 3 · Relapsing MS · no_result_found

  • SCALA

    Completed · Phase 1 · Progressive MS · result_in_paper_unread

For information only, not medical advice. Talk to your neurologist before changing treatment.

Hypotheses involving this medicine

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Lab studies

Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.

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