FDA Approves Sevenfact (coagulation factor VIIa recombinant-jncw) for Adults and Adolescents with Hemophilia A or B and Inhibitors

April 01, 2020 -- The U.S. Food and Drug Administration today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news

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ConclusionsEmicizumab pharmacokinetics in PwHA was described with dose-independent parameters. Body weight was an important predictor of emicizumab pharmacokinetics. All three dosing regimens are predicted to achieve similar exposure associated with clinically meaningful prevention of bleeding.
Source: Clinical Pharmacokinetics - Category: Drugs & Pharmacology Source Type: research
An experimental gene therapy for hemophilia A from BioMarin Pharmaceutical Inc. — promising a one-shot fix for the genetic cause of the bleeding disorder — continues to hold patients' bleeds to less than one a year after four years. The results of the ongoing study are important as San Rafael-based BioMarin's (NASDAQ: BMRN) gene therapy, called Roctavian and known scienti fically as valoctogene roxaparvovec, nears an Aug. 21 decision date from the Food and Drug Administration. If approved, it…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news
roup Abstract BACKGROUND:  von Willebrand factor (VWF) is crucial for optimal dosing of factor VIII (FVIII) concentrate in hemophilia A patients as it protects FVIII from premature clearance. To date, it is unknown how VWF behaves and what its impact is on FVIII clearance in the perioperative setting. AIM:  To investigate VWF kinetics (VWF antigen [VWF:Ag]), VWF glycoprotein Ib binding (VWF:GPIbM), and VWF propeptide (VWFpp) in severe and moderate perioperative hemophilia A patients included in the randomized controlled perioperative OPTI-CLOT trial. METHODS:  Linear mixed effects modeling...
Source: Thrombosis and Haemostasis - Category: Hematology Authors: Tags: Thromb Haemost Source Type: research
This article describes a patient successfully treated with recombinant factor VIIa, porcine factor VIII, plasmapheresis, rituximab, and high-dose corticosteroids.
Source: Journal of the American Academy of Physician Assistants - Category: Primary Care Tags: Case Report Source Type: research
Patients with hemophilia are at a high risk of developing arthropathy and so are more likely to require surgery during their lifetime; in particular, major orthopedic surgery [1]. The management of patients with hemophilia undergoing surgery has additional considerations, as they are more likely to experience excessive or prolonged bleeding and associated complications, compared with patients without hemophilia [2].
Source: Thrombosis Research - Category: Hematology Authors: Tags: Letter to the Editors-in-Chief Source Type: research
Classification of the X-linked recessive bleeding disorder Hemophilia A (HA) is based on residual Factor VIII activity level (FVIII:C) that largely correlates with bleeding severity. Understanding the underlying basis for bleeding phenotypes differing from those predicted by FVIII:C should refine classification of patients, clarify genotype-phenotype correlations, and improve clinical management of persons with HA.
Source: Thrombosis Research - Category: Hematology Authors: Tags: Letter to the Editors-in-Chief Source Type: research
Hemophilia A is a bleeding disorder due to the deficiency of coagulation factor VIII (FVIII). According to resident FVIII activity, the disease was divided into mild type (FVIII:c  > 5 IU/dL), moderate type (FVIII:c 1–5 IU/dL) and severe type (FVIII:c 
Source: Thrombosis Research - Category: Hematology Authors: Tags: Letter to Editors-in-Chief Source Type: research
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Source: Acta Clinica Belgica - Category: General Medicine Authors: Source Type: research
Iliacus hematoma syndrome (IHS) is characterized as a retroperitoneal compartment neuropathy caused by bleeding within the iliacus muscle leading to hematoma formation and compression upon the femoral nerve [1]. Subsequently, it shows symptoms such as weakness of the iliopsoas muscle, numbness, loss of knee-jerk, and sensory loss of anteromedial thigh [2]. IHS may be precipitated by trauma alone but have characteristically been described in patients with hemophilia and those on anticoagulation therapy [3, 4].
Source: Injury - Category: Orthopaedics Authors: Source Type: research
Condition:   Hemophilia A Intervention:   Biological: Moroctocog-alfa (AF-CC) Sponsor:   Pfizer Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
More News: Bleeding | Drugs & Pharmacology | Food and Drug Administration (FDA) | Haemophilia | Hemophilia