The first condensate-set disease (CAD) hemolytic treatment drug! Sanofi tonic C1s inhibitor sutimlimab is given priority by the FDA!
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Last Update: 2020-05-15
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Source: Internet
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Author: User
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2020 May 15 News /BioValleyBIOON / - Sanofi (Sanofi) today announced that the US Food and Drug Administration (
FDA) have been accepted for treatment of primary sutimlimab cold agglutinin disease (CAD) biological license application hemolysis adult patient (BLA), and granted priority reviewsutimlimab is an investigational monoclonal antibody to target the cause of the intrinsic CAD hemolysis by selectively inhibiting complement C1sIf approved, sutimlimab will be the first drug treatment and only a CAD hemolysisFDAhave specified a target action date for the BLA 2020 November 13CAD is a rare, serious, chronic, autoimmune a a a disease of a hemolytic anemia, In this disease, the immune system of the complement system the body mistakenly attacks healthy red blood cells and lead to rupture of red blood cells (hemolysis)CAD patients may experience chronic anemia, severe fatigue, acute hemolytic crisis and other potential complications, including the risk of thromboembolic events and early death increasedIt is estimated that about 5000 cases of CAD patients in the United StatessutimlimabBLA submitted, based on the A key part of a single arm, open-label Phase III study conducted in CARDINAL primary CAD in patients (n = 24) resultsThese data have been published in the 2019, the 61st American Society of Hematology Annual Meeting (ASH2019), confirmed sutimlimab met its primary composite efficacy endpoint, the index is defined as the proportion of patients who achieve all of the following complex criteria: the treatment assessment time point (23 weeks 25 weeks, 26 weeks average) increase in hemoglobin levels compared to baseline ≥2g / dL hemoglobin level reaches or ≥12g / dL, no transfusion during 5-26 weeksIn addition, experiments show that, sutimlimab reached secondary endpoints: show improved key indicators of disease processes, including improved hemoglobin, bilirubin normalization, functional assessment of chronic treatment (FACIT) improve the fatigue scoreJohnReed DrSanofi global research and development director, said: "Currently, patients with cold agglutinin no approved treatment options for these patients experience chronic anemia and severe fatigue, which can cause serious and sustained impact on their livesresults from 26 weeks key CARDINAL III study clearly show, sutimlimab having a therapeutic effect clinical significance of complement-mediated hemolysis (causes of anemia and fatigue)If approved, sutimlimab will be the first and only to obtain < br /> FDAapproved treatment options can uniquely solve the problem of hemolysis activate C1, and help reduce the burden of chronic disease patients with CAD"
sutimlimab is a potentially pioneering, research, human monoclonal antibodies, specifically designed to selectively target and inhibit the serine proteases C1s C1 complexes, a C1 complexes activate the immune system is the first step in the classical complement pathwayThe classical complement pathway is a part of the innate immune system, its activation is a central mechanism CAD hemolysisBy targeting inhibiting C1s, sutimlimab believed to block the activation of the classical complement pathway, thereby preventing the activation of CAD and C1 hemolysissutimlimab having a novel mechanism of action and a high degree of target specificity, selectively inhibiting the disease process upstream of the classical complement pathway, while leaving intact alternative complement pathway and the lectin complement pathway and immune surveillanceCurrently, Sanofi being evaluated in phase III trials CADENZA sutimlimab untransfused for CAD the patient has recently, the company also investigating sutimlimab for the treatment of immune thrombocytopenic purpura (ITP) patientsEarlier, the USFDAsutimlimab breakthrough drugs that have been granted eligibility (BTD) and orphan status (ODD)sutimlimab is an investigational drug, is currently in clinical development, its safety and efficacy has not been evaluated by any regulatory agency(Biovalley Bioon.com)ORIGINAL: FDA grantspriorityreviewofsutimlimab, potentialfirst app rovedtreatmentofhemolysisinadultpatientswithColdAgglutininDisease
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