MOJ ISSN: 2373-4442MOJI

Immunology
Mini Review
Volume 3 Issue 2 - 2016
Therapeutic Monoclonal Antibodies Approved by FDA in 2015
Henry Hongrong Cai*
Medical Director, Pharmacovigilance and Drug Safety, USA
Received:May 02, 2016 | Published: May 06, 2016
*Corresponding author: Henry Hongrong Cai, Medical Director, Pharmacovigilance and Drug Safety, inVentiv Health Clinical, 95 Cynthia Road Newton, MA 02459, USA, Tel: 1-617-584-6628; Email:
Citation: Cai HH (2016) Therapeutic Monoclonal Antibodies Approved by FDA in 2015. MOJ Immunol 3(2): 00087. DOI: 10.15406/moji.2016.03.00087

Keywords

Monoclonal antibodies; Hybridoma; FDA

Mini Review

In 1975, Monoclonal antibody (mAb) technique was created by Georges Köhler, César Milstein, and Niels Kaj 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 mAb Muromonab-CD3 (trade name Orthoclone OKT3) to reduce acute rejection in patients with organ transplants, since then, as of May 1, 2016, FDA has approved 62 therapeutic mAbs [1]. Among them, this year already approved 4, including ANTHIM (March 18, 2016) [2], TALTZ (March 22, 2016) [3], CINQAIR (March 23, 2016) [4], and INFLECTRA (April 5, 2016) [5]. In 2015, FDA totally approved 10 therapeutic monoclonal antibodies, (Table 1 & 2), [6-15]. It is historical high since first approval in 1992. This mini review focuses briefly on the characteristics of the antibodies approved in 2015 by FDA.

Drug Name

Active Ingredients

Company

Approval Date

Cosentyx

Secukinumab

Novartis Pharms Corp

1/21/2015

Opdivo

Nivolumab

Bristol Myers Squibb

3/4/2015

Unituxin

Dinutuximab

United Therap

3/10/2015

Praluent

Alirocumab

Sanofi Aventis

7/24/2015

Praxbind

Idarucizumab

Boehringer Ingelheim

10/16/2015

Repatha

Evolocumab

Amgen Inc

8/27/2015

Darzalex

Daratumumab

Janssen Biotech

11/16/2015

Nucala

Mepolizumab

Glaxosmithkline Llc

11/4/2015

Portrazza

Necitumumab

Eli Lilly Co

11/24/2015

Empliciti

Elotuzumab

Bristol Myers Squibb

11/30/2015

Table 1: Therapeutic Monoclonal Antibodies Approved by FDA in 2015.

Drug Name

Indications and Usage

Warnings and Precautions

Mechanism of Action

Cosentyx

Moderate to severe plaque psoriasis

Infections Tuberculosis (TB) Crohn’s Disease Hypersensitivity Reactions

IL-17A antagonist

Opdivo

Moderate to severe plaque psoriasis

Immune-mediated adverse reactions; Hypo-/hyperthyroidism; Embryo fetal toxicity

A programmed death receptor-1 (PD-1) blocking antibody

Unituxin

Pediatric Neuroblastoma

Infusion reaction; Neuropathy

GD2­ expressing cells ADCC and CDC

Praluent

Heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease

Allergic Reactions

PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor

Praxbind

Reversal of the Anticoagulant effects of dabigatran (pradaxa® ) for emergency

Thromboembolic Risk; Hypersensitivity reactions

A specific reversal agent

Repatha

HeFH or CVD, tolerated statin therapy

Allergic Reactions

Inhibiting the binding of PCSK9 to LDLR

Darzalex

Multiple Myeloma

Infusion reactions; interference with cross-matching

Inhibit the growth of CD38 expressing tumor cells by inducing apoptosis

Nucala

Severe Asthma

Hypersensitivity reactions

Interleukin-5 antagonist

Portrazza

Metastatic squamous NSCLC

Cardiopulmonary arrest and/or sudden death; Hypomagnesemia

Block the binding of EGFR to its ligands

Empliciti

Multiple myeloma who have received one to three prior therapies

Infusion reactions; Infections; Second Primary Malignancies; Hepatotoxicit

Target Signaling Lymphocytic Activation Molecule Family member 7

Table 2: Some Characteristics of the Therapeutic Mab Approved by FDA in 2015.

References

  1. Henry HC (2014) Risk Evaluation and Mitigation Strategy for Approved Therapeutic Antibodies. MOJ Immunology 1(5): 00028.
  2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf
  3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf
  4. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf
  5. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf
  6. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf
  7. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf
  8. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125516s000lbl.pdf
  9. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559Orig1s000lbledt.pdf
  10. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761025lbl.pdf
  11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125522s000lbl.pdf
  12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf
  13. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf
  14. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf
  15. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf
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