FDA approves Novartis Adakveo (crizanlizumab, also known as SEG101) for listing
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Novartis(http:// announcedthat the U.SFDA(http://approved the launch of its potential heavy-duty therapy, Adaklizumab, also known as SEG101, to reduce the frequency of vascular blocking crisis in patients over the age of 16 with sickle cell anemia (SCD)a monoclonal antibody that targets P-selectinAdakveoFDA approval was nearly two months ahead of scheduleIt is also the third innovative treatment approved by the FDA in two days, following the cancer treatment sprekinsa of Baiji Shenzhou, Brukinsa and Theotroja, the antibiotic of Yanyeyi
a monoclonal antibody targeted at P-selectorsP-selectin is a bonding molecule found in vascular endothelial cells and platep that contributes to intercellular interactions (including endothelial cells, platelets, RBC, sickle RBC, and white blood cells), resulting in multicellular adhesion and aggregation, which in turn blocks blood vesselsby combining with P-selecter, Adakevo prevents VOCPreviously, it has been certified by the FDA as a breakthrough therapy, and is eligible for priority review of orphan drugsThis approval is based on the results of a randomized clinical
trial of 198 patients with a history of VOC (http:// The results showed that patients treated with Adakveo were treated 1.63 times a year for VOC, a 45% reduction compared to the control group (2.98) (p-0.010) and 36% of patients treated with Adakveo did not have any VOC in clinical trials, and Adakeveo delayed the first occurrence of VOC after treatment from 1.4 months to 4.1 months
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