FDA approves the expansion of the heavy-duty drug Dupixent to extend indications
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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today,the FDA's(http://announced that it has approved the expansion alphylopathy of the heavy-
drug(http://Dulumupi, developed jointly by Sanofiinchttp://and Regeneron, to treat adult patients with chronic sinusitis (CRSw) with nasal polypsDupixent is currently approved to treat three types of type 2 inflammation-induced indications, including moderate to severe eczema, moderate to severe asthma, and CRSwNPAbout Dupixent
Dupixent is a whole-humanized monoclonal antibody that inhibits the IL-4 and IL-13 signaling pathwaysThese two proteins play a key role in type 2 inflammationThe clinicaltrial (http:// data from Dupixent show that inhibition of IL-4 and IL-13 reduces type 2 inflammation and plays an important role in CARSwNP, asthma, and eczema FDA approval is based on the results of two key clinical trials (SINUS-24 and SINUS-52) In these trials, Dupixent reached all major and minor clinical endpoints After 24 weeks of treatment, a number of patient indicators improved significantly In patients treated with corticosteroid nasal spray, the severity of nasal congestion/nasal obstruction decreased by 57% (SINUS-24) and 51% (SINUS-52), respectively The control group who received only standard treatment decreased by only 19% and 15% The nasal polyps index of patients treated with Dupixent decreased by 33% and 27%, respectively, while the control group increased by 7% and 4% Compared to the control group, Dupixent treatment significantly reduced the patient's need to use systemic corticosteroids and surgery
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