Table 1.
USFDA mAb Approvals in 2017.
| mAb | Target(s) Mode of Action |
Indication(s) | Adverse Effects |
|---|---|---|---|
| Brodalumab (Siliq) Valeant Pharmaceuticals |
IL-17RA antagonist | Moderate to severe plaque psoriasis | Severe infections, suicidal and behavior ideation |
| Dupilumab (Dupixent) Regeneron Pharmaceuticals |
IL-4 Rα antagonist Inhibits IL-4 and IL-13 signaling |
Moderate to severe atopic dermatitis | Injection site reactions, infections, conjunctivitis, blepharitis, keratitis, eye pruritus, dry eye |
| Serilumab (Kevzara) Sanofi |
IL-6 R antagonist | Moderately to severe active rheumatoid arthritis | Hearing deficiency, potential for severe opportunistic infections, neutropenia, increased ALT, injection site erythema, |
| Guselkumab (Tremfya) Janssen Biotech |
IL-23 inhibitor Inhibits the release of pro-inflammatory chemokines |
Moderate to severe plaque psoriasis | May increase risk of infections, headache, injection site reactions, arthralgia, diarrhea, gastroenteritis, tinea infections, herpes simplex infections |
| Benralizumab (Fasenra) Astra Zeneca |
IL-5 R binding on eosinophils; attracts Natural Killer Cells to induce apoptosis | Severe asthma with an eosinophilic phenotype | Headache, pharyngitis, pyrexia, hypersensitivity reactions |
| Ocrelizumab (Ocrevus) Genentech |
CD20 antigen on B lymphocytes ADCC and complement lysis |
Multiple sclerosis | Upper respiratory infections, infusion reaction |
| Inotuzumab ozogamicin (Besponsa) Pfizer |
CD-22 directed ADC with N-acetyl-gamma-calicheomicin | Relapsed or refractory B-cell precursor acute lymphoblastic leukemia | Hepatotoxicity, veno-occlusive disease or sinusoidal obstruction syndrome; thrombocytopenia; neutropenia; infection; anemia; leukopenia; fatigue; hemorrhage |
| Avelumab (Bavencio) EMD Serono /Pfizer |
PD-L1–blocks interaction between PD-L1 and PD-1 and B7-1 | Metastatic Merkel cell carcinoma | Fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, peripheral edema |
| Durvalumab (Imfinzi) Astra Zeneca |
PD-L1–blocks T-cell function and activation via PD-1 and CD80 | Advanced or metastatic urothelial carcinoma and Stage III non- small cell lung cancer | Fatigue, musculoskeletal pain, constipation, infections, peripheral edema, decreased appetite |
| Emicizumab–kxyh (Hemlibra) Genentech |
Bispecific factor IXa and factor X directed–to restore missing factor VIII | Prevention or reduction of bleeding episodes in patients with Hemophilia A | Thrombotic microangiopathic and thrombic effects, injection site reactions, headaches |