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Top 10 Antibody Drug Approvals from FDA 1980-2022
Top 10 Antibody Drug Approvals from FDA 1980-2022
Biointron2023-12-18Read time: 4 mins
Antibody drugs have become an increasingly important class of therapeutics for a wide range of diseases. In this article, we will introduce the top 10 antibody drugs that have been approved by regulatory agencies from 1980 to 2022 and provide some information about their development history and the diseases they are used to treat.
Humira (adalimumab): Humira was approved by the FDA in 2002 and is used to treat rheumatoid arthritis, psoriasis, and other autoimmune disorders. It was the first fully human antibody drug approved by the FDA.
Keytruda (pembrolizumab): Keytruda was approved by the FDA in 2014 and is used to treat melanoma, lung cancer, and other cancers. It was the first PD-1 inhibitor approved by the FDA.
Herceptin (trastuzumab): Herceptin was approved by the FDA in 1998 and is used to treat HER2-positive breast cancer. It was the first monoclonal antibody drug approved for cancer treatment.
Remicade (infliximab): Remicade was approved by the FDA in 1998 and is used to treat Crohn's disease, rheumatoid arthritis, and other autoimmune disorders. It was the first anti-TNF-alpha antibody drug approved by the FDA.
Rituxan (rituximab): Rituxan was approved by the FDA in 1997 and is used to treat non-Hodgkin's lymphoma and other blood cancers. It was the first monoclonal antibody drug approved for cancer treatment.
Opdivo (nivolumab): Opdivo was approved by the FDA in 2014 and is used to treat melanoma, lung cancer, and other cancers. It was the first PD-1 inhibitor approved by the FDA.
Avastin (bevacizumab): Avastin was approved by the FDA in 2004 and is used to treat colon cancer, lung cancer, and other cancers. It was the first anti-angiogenic antibody drug approved by the FDA.
Lucentis (ranibizumab): Lucentis was approved by the FDA in 2006 and is used to treat macular degeneration, diabetic retinopathy, and other eye diseases. It was the first antibody drug approved for ophthalmic use.
Stelara (ustekinumab): Stelara was approved by the FDA in 2009 and is used to treat psoriasis, psoriatic arthritis, and Crohn's disease. It was the first interleukin inhibitor approved by the FDA.
Tecentriq (atezolizumab): Tecentriq was approved by the FDA in 2016 and is used to treat bladder cancer, lung cancer, and other cancers. It was the first PD-L1 inhibitor approved by the FDA.
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Complementarity-determining regions (CDRs) are polypeptide sequences within antibodies (Abs) that dictate the specific recognition and binding of antigens. Antibodies are part of the human immune response and are composed of two heavy and two light protein chains. These chains are divided into variable (V) and constant (C) regions, with the V region responsible for binding to unique antigens.
Antigens are molecules or molecular structures that are recognized by the immune system, particularly by antibodies, T cells, and B cells. The immune response to an antigen varies depending on the antigen type and the part of the immune system involved. This interaction underpins immunity by helping the body distinguish between self and non-self molecules.