Table 1. Recently approved protein and peptide therapeutics [9].
Protein or peptide | Brand name, manufacturer | Year of FDA approval | Molecular weight | Route of administration | Half-life | Target disease |
---|---|---|---|---|---|---|
Ziv-aflibercept | Zaltrap®, Regeneron and Sanofi | 2012 | 115 kDa | Intravenous infusion | 4-7 days | Metastatic colorectal cancer |
Ocriplasmin | Jetrea®, ThromboGenics Inc. | 2012 | 27.2 kDa | Intravitreal injection | NA | Symptomatic vitreomacular adhesion |
Raxibacumab | Abthrax®, GlaxoSmith Kline | 2012 | 146 kDa | Intravenous infusion | 16-19 days | Inhalational anthrax |
Belimumab | Benlysta®, Human Genome Sciences, Inc. | 2011 | 147 kDa | Intravenous infusion | 19.4 days | Systemic lupus erythematosus |
Ipilimumab | Yervoy ®, E.R. Squibb & Sons, L.L.C | 2011 | 148 kDa | Intravenous infusion | 15.4 days | Unresectable or metastatic melanoma |
Belatacept | Nulojix®, E.R. Squibb & Sons, L.L.C | 2011 | 90 kDa | Intravenous infusion | 8-10 days | Prophylaxis of organ rejection (kidney transplant) |
Brentuximab vedotin | Adcetris®, Seattle Genetics, Inc. | 2011 | 153 kDa | Intravenous infusion | 4-6 days | Hodgkin lymphoma and systemic anaplastic large cell lymphoma |
Asparaginase Erwiniachryanthemi | Erwinaze, Jazz Pharmaceuticals, Inc. | 2011 | 35 kDa | Intramuscular injection | 16 h | Acute lymphoblastic leukemia |
Aflibercept | Eylea®, Regeneron Pharmaceuticals, Inc. | 2011 | 115 kDa | Intravitreal injection | 5-6 days | Neovascular (Wet) age-related macular degeneration (AMD), Macular edema following central retinal vein occlusion (CRVO) |
Velaglucerase alfa | Vpriv®, Shire US Manufacturing Inc. | 2010 | 63 kDa | Intravenous infusion | 11-12 min | Type 1 Gaucher disease |
Tesamorelin | Egrifta®, EMD Serono, Inc. | 2010 | ∼5 kDa | Subcutaneous injection | 26-38 min | Lipodystrophy |
Tocilizumab | Actemra®, Genen-tech, Inc. | 2010 | 148 kDa | Subcutaneous injection and Intravenous infusion | 6.3 days | Rheumatoid and systemic juvenile idiopathic arthritis |
Collagenase clostridium histolyti-cum | Xiaflex®, Auxilium Pharmaceuticals, Inc. | 2010 | ∼113 kDa | Intralesional injection | NA | Dupuytren's contracture |
Alglucosidase alfa | Lumizyme®, Genzyme Corporation | 2010 | 109 kDa | Intravenous infusion | 2.4 h | Pompe disease |
Denosumab | Prolia®, Amgen Inc. | 2010 | 147 kDa | Subcutaneous injection | 25.4 days | Postmenopausal osteoporosis |
IncobotulinumtoxinA | Xeomin, Merz Aesthetics. Inc. | 2010 | 150 kDa | Intramuscular injection | NA | Cervical dystonia |
Pegloticase | Krystexxa®, Savient Pharmaceuticals, Inc. | 2010 | 540 kDa | Intravenous infusion | NA | Chronic gout |
NA: not available, Source: labels.fda.gov.