Mini Review Volume 5 Issue 1
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
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); |
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.
©2017 Cai. This is an open access article distributed under the terms of the, which permits unrestricted use, distribution, and build upon your work non-commercially.