MOJ ISSN: 2373-4442MOJI

Immunology
Letter to Editor
Volume 1 Issue 5 - 2014
Risk Evaluation and Mitigation Strategy for Approved Therapeutic Antibodies
Henry Hongrong Cai*
Medical Director, Ventive Health Clinical, USA
Received: October 31, 2014 | Published: December 11, 2014
*Corresponding author: Henry Hongrong Cai, Medical Director, Ventive Health Clinical, 95 Cynthia Road Newton, MA 02459, USA, Tel: 617-795-0547; 617-581-5161; Email: @
Citation: Cai HH (2014) Risk Evaluation and Mitigation Strategy for Approved Therapeutic Antibodies. MOJ Immunol 1(5): 00028. DOI: 10.15406/moji.2014.01.00028 10.15406/moji.2014.01.00028

Abbreviations

mAb: Monoclonal Antibody; MSPA: Moderate to Severe Persistent Asthma; CIU: Chronic Idiopathic Urticaria; α4: α4-Subunit of α4β1 and α4β7 Integrins; MS: Multiple Sclerosis; CD: Crohn’s Disease; PML: Progressive Multifocal Leukoencephalopathy; PNH: Paroxysmal Nocturnal Hemoglobinuria; aHUS: Atypical Hemolytic Uremic Syndrome; p40: p40 Subunit of IL-12 and IL-23; Ps: Psoriasis; PsA: Psoriatic Arthritis; RPLS: Reversible Posterior Leukoencephalopathy Syndrome; RA: Rheumatoid Arthritis; PJIA: Polyarticular Juvenile Idiopathic Arthritis; SJIA: Systemic Juvenile Idiopathic Arthritis; CTLA-4: Human Cytotoxic T-lymphocyte Antigen-4; UMM: Unresectable Or Metastatic Melanoma; SFIMAR: Severe and Fatal Immune-Mediated Adverse Reactions such as Enterocolitis; REMS: Risk Evaluation And Mitigation Strategy

Letter To Editor

In 1975, Monoclonal antibody (mAb) technique was created by Georges Kohler, Cesar Milstein, and NielsKaj Jerne by using mouse x mouse hybridoma, they shared the Nobel Prize in Physiology or Medicine in 1984 for the discovery. 8 years later, in 1992 FDA approved first therapeutic mAbMuromonab-CD3 (trade name Orthoclone OKT3) for to reduce acute rejection in patients with organ transplants, since then, as of December 2014, FDA has approved 42 therapeutic mAbs. Among them 6 need risk evaluation and mitigation strategy (REMS) (Table 1). These therapeutic mAb targets at components of immune system, soluble or membrane to achieve therapeutic effect, inevitably causing immune-mediated adverse reaction [1-6]. REMS includes medication guide and elements to assure safe use to maintain the benefit overweight the risk.
According to the law Food and Drug Administration Amendments Act- sometimes called “FDAAA”-enacted in 2007, FDA may require a REMS as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. REMS assessments will be submitted to FDA at 18 months, 3 years, 5 years, and 7 years after approval of the original REMS. On Dec 22, 2011 Xolair was successfully release from the REMS [7].

Approval date

MAH

Drug name

mAb

Target

Indication

REMS

June 20 2003

GENENTECH

Xolair

Omalizumab

IgE

MSPA, CIU

Anaphylaxis

Nov 23 2004

BIOGENIDEC

Tysabri

Natalizumab

α4

MS, CD

PML

Mar 16 2007

ALEXION

Soliris

Eculizumab

C5

PNH, aHUS

Meningococcal infections

Sept 25 2009

CENTOCOR ORTHO

Stelara

Ustekinumab

p40

Ps, PsA

RPLS

Jan 08 2009

GENENTECH

Actemra

Tocelizumab

IL-6R

RA, PJIA, SJIA

Serious infection

Mar 25 2011

BMS

Yervoy

Ipilimumab

CTLA-4

UMM

SFIMAR

Table 1: Approved therapeutic mAb with risk evaluation and mitigation strategy (REMS).

References

  1. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf
  2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf
  3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125166s368s380lbl.pdf
  4. http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125261s114lbl.pdf
  5. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s092lbl.pdf
  6. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf
  7. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm393231.htm
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