Therapeutic Monoclonal Antibodies Approved by FDA in 2016

doi:10.15406/moji.2017.05.00145

MOJ

eISSN: 2373-4442

Immunology

Mini Review Volume 5 Issue 1

Therapeutic Monoclonal Antibodies Approved by FDA in 2016

Henry Hongrong Cai

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Pharmacovigilance and drug safety, EMD Serono and InVentive Health Clinical, USA

Correspondence: Henry Hongrong Cai, Ventive Health Clinical, 95 Cynthia Road Newton, MA 02459, USA, Tel 617-581-5161

Received: January 01, 1971 | Published: January 20, 2017

Citation: Cai HH (2017) Therapeutic Monoclonal Antibodies Approved by FDA in 2016. MOJ Immunol 5(1): 00145. DOI: 10.15406/moji.2017.05.00145

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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