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In adults and adolescents with eosinophilic esophagitis, common symptoms include difficulty swallowing, difficulty eating, and food getting stuck in the esophagus. [9] Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway. [9] Dupilumab is the first treatment for prurigo nodularis approved by the FDA. [10]
The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug's approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof, for which the drug is approved, as well as ...
In the SINUS-24 and SINUS-52 trials, the safety of Dupixent in adults was generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥1%) compared to placebo in SINUS-24 and SINUS-52 (24-week safety pool) were injection site reactions, eosinophilia, insomnia ...
Currently, there are two FDA approved antibody therapies for Alzheimer's disease, Aducanemab and Lecanemab. Aducanemab has received accelerated approval while Lecanemab has received full approval. [25] Several clinical trials using passive and active immunization have been performed and some are on the way with expected results in a couple of ...
Mepolizumab was approved for medical use in the European Union in December 2015. [5] In September 2020, mepolizumab was approved in the United States to treat adults and children aged twelve years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease. [5]
More than ten percent of people taking Anakinra have injection site reactions, headaches, and have increased cholesterol levels. [1] Recipients have eight percent more patients decrease white blood cells counts, two percent more patients decrease platelets counts, one percent more patients get severe infections (4.5% for patients with asthma compared to 0% placebo patients with asthma). [1]
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021. [5] [6] [11] [8] [12] Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, [6] and full approval in February 2023. [7]
Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica.