Product licences for alemtuzumab and multiple sclerosis

The Lancet

Volumn 383, Issue 9920, 2014, Pages 867-868

  Coles, Alasdair J ^a   Compston, Alastair ^a  

^a Cambridge Biomedical Campus   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; BETA1A INTERFERON;

DRUG EFFICACY; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; RISK FACTOR; STUDY DESIGN; DRUG APPROVAL; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC);

ANTIBODIES, MONOCLONAL, HUMANIZED; DRUG APPROVAL; HUMANS; MULTIPLE SCLEROSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; UNITED STATES;

EID: 84895730431     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)60440-2     Document Type: Letter

References (5)

1. Coles AJ, Compston DA, Selmaj KW, et al. Alemtuzumab vs interferon beta-1a in early multiple sclerosis. N Engl J Med 2008; 359: 1786-801.
2. Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing remitting multiple sclerosis: a randomized controlled phase 3 trial. Lancet 2012; 380: 1819-28.
3. Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012; 380: 1829-39.
4. Moreau T, Coles A, Wing M, et al. Transient increase in symptoms associated with cytokine release in patients with multiple sclerosis. Brain 1996; 119: 225-37.
5. US FDA. 2013 Meeting Materials, Peripheral and Central Nervous System Drugs Advisory Committee. November 13, 2013. http://www.fda.gov/ AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/ucm346581.htm (accessed Jan 21, 2014).