MOJ ISSN: 2373-4442MOJI

Immunology
Mini Review
Volume 5 Issue 1 - 2017
Therapeutic Monoclonal Antibodies Approved by FDA in 2016
Henry Hongrong Cai*
Medical Director, Pharmacovigilance and Drug Safety, USA
Received: January 13, 2017 | Published: January 20, 2017
*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 (2017) Therapeutic Monoclonal Antibodies Approved by FDA in 2016. MOJ Immunol 5(1): 00145. DOI: 10.15406/moji.2016.05.00145

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 January 11, 2017, FDA has approved 68 therapeutic mAbs [1]. Among them, in 2015, FDA totally approved 10 therapeutic monoclonal antibodies [2], it is historical high since first approval in 1992; in 2016, once again FDA approved 10 therapeutic antibodies. This mini review focuses briefly on the characteristics of the antibodies approved in 2016 by FDA [3-12], (Table 1&2).

Drug Name

Active Ingredients

Company

Approval Date

Anthim

Obiltoxaximab

Elusys Therapeutics Inc

3/18/2016

Taltz

Ixekizumab

Eli Lilly and Co

3/22/2016

Cinqair

Reslizumab

Teva Respiratory Llc

3/23/2016

Tecentriq

Atezolizumab

Genentech Inc

5/18/2016

Zinbryta

Daclizumab

Biogen

5/27/2016

Amjevita

Adalimumab-Atto

Amgen Inc

9/23/2016

Stelara

Ustekinumab

Janssen Biotech

9/23/2016

Tecentriq

Atezolizumab

Genentech Inc

10/18/2016

Lartruvo

Olaratumab

Eli Lilly and Co

10/19/2016

Zinplava

Bezlotoxumab

Merck Sharp Dohme

10/21/2016

Table 1: Therapeutic Monoclonal Antibodies Approved by FDA in 2016.

Drug Name

Indications and Usage

Warnings and Precautions

Mechanism of Action

Anthim

Inhalational anthrax due to B. anthracis

Hypersensitivity reactions, including anaphylaxis

Against the protective antigen of Bacillus anthracis

Taltz

Moderate to severe plaque psoriasis

Infection; Tuberculosis (TB); Hypersensitivity; Inflammatory Bowel Disease

Interleukin-17A antagonist

Cinqair

Add-on maintenance treatment of patients with severe asthma

Anaphylaxis

Interleukin-5 antagonist

Tecentriq

Locally advanced or metastatic urothelial carcinoma

Immune-related disorders

Programmed death- ligand 1 PD-L1 blocking

Zinbryta

Relapsing forms of multiple sclerosis (MS)

Hepatic injury and Other Immune-Mediated Disorders

Interleukin-2 receptor blocking

Amjevita

Rheumatoid Arthritis (RA) Juvenile Idiopathic Arthritis (JIA);
Psoriatic Arthritis (PsA); Ankylosing Spondylitis (AS);
Adult Crohn’s Disease (CD); Ulcerative Colitis (UC);
Plaque Psoriasis (Ps)

Serious infection and malignancy

Tumor necrosis factor (TNF) blocker

Stelara

Moderate to severe plaque psoriasis (Ps); active psoriatic arthritis (PsA); active Crohn’s disease (CD)

Serious infection and malignancy Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Interleukin-12 and -23 antagonist

Tecentriq

Locally advanced or metastatic urothelial carcinoma; Metastatic non-small cell lung cancer

Immune-related disorders

Programmed death-ligand 1 (PD-L1) blocking

Lartruvo

Soft tissue sarcoma (STS)

Infusion-Related Reactions; Embryo-Fetal Toxicity

Platelet-derived growth factor receptor alpha (PDGFR-α) blocking

Zinplava

Reduce recurrence of Clostridium difficile infection (CDI)

Heart Failure

Binding Clostridium difficile toxin B

Table 2: Some Characteristics of the Therapeutic Mab Approved by FDA in 2016.

References

  1. Cai HH (2014) Risk Evaluation and Mitigation Strategy for Approved Therapeutic Antibodies. MOJ Immunology 1(5): 00028.
  2. Cai HH (2016) Therapeutic Monoclonal Antibodies Approved by FDA in 2015. MOJ Immunol 3(2): 00087.
  3. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125509lbl.pdf
  4. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf
  5. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761033lbl.pdf
  6. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034Orig1s000lbl.pdf
  7. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf
  8. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024Orig1s000Lbl.pdf
  9. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761044lbl.pdf
  10. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041s000lbl.pdf
  11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761038lbl.pdf
  12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf
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