Delving into the Latest Updates on Factor IX(Bio Products Laboratory) with Synapse

Overview

Basic Info

Drug Type

Non-recombinant coagulation factor

Synonyms

Factor IX, High purity Factor IX concentrate, Replenine-VF

Target

factor IX

Action

stimulants

Mechanism

factor IX stimulants(Coagulation factor IX stimulants), Blood coagulation pathway activation

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia B

Inactive Indication-

Originator Organization

Bio Products Laboratory USA, Inc.

Active Organization

Bio Products Laboratory USA, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United Kingdom (09 Aug 1999),

Hemophilia B

Regulation-

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AbstractAimHemophilic pseudotumor (HP) is a very rare complication of hemophilia seen in only 1–2% of the cases. Although it is much more common in long bones, pelvis and small bones of hands and feet and very rarely involving jaw bones.Method and resultIn the present case, the presence of a rare hemophilic pseudotumor of the mandible with the positive history of Hemophilia B justifies that the history, clinical and radiological examinations were sufficient to arrive at conclusive diagnosis precluding invasive diagnostic procedures such as biopsy hence avoiding the risk of hemorrhage, infection, or fistula. This case also highlights that patient was conservatively managed with Factor IX replacement alone with a very good clinical outcome.ConclusionHP should be considered as a differential diagnosis of any progressive swelling of hard and soft tissues occurring in a patient with severe haemophilia.

01 Dec 2021·TrialsQ4 · MEDICINE

Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study

Q4 · MEDICINE

ArticleOA

Author: Albrice Levrat ; Jacques Duranteau ; Jean-Stéphane David ; Jean-Luc Bosson ; Delphine Garrigue ; Julien Pottecher ; Pierre Bouzat ; Jonathan Charbit ; Bruno Riou ; Guillaume Marcotte ; Karim Asehnoune ; Jean-François Payen ; Paër-Selim Abback ; Marc Leone

AbstractBackgroundOptimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four-factor prothrombin complex concentrate (PCC) might be useful in this context. Our main hypothesis is that four-factor PCC in addition to a massive transfusion protocol decreases blood product consumption at day 1 in severe trauma patients with major bleeding.MethodsThis is a prospective, randomized, multicenter, double-blind, parallel, controlled superiority trial. Eligible patients are trauma patients with major bleeding admitted to a French level-I trauma center. Patients randomized in the treatment arm receive 1 mL/kg (25 IU/ml of Factor IX/Kg) four-factor PCC within 1-h post-admission while patients randomized in the controlled group receive 1 mL/kg of saline solution 0.9% as a placebo. Treatments are given as soon as possible using syringe pumps (120 mL/h). The primary endpoint is the amount of blood products transfused in the first 24 h post-admission (including red blood cells, frozen fresh plasma, and platelets). The secondary endpoints are the amount of each blood product transfused in the first 24 h, time to achieve prothrombin time ratio < 1.5, time to hemostasis, number of thrombo-embolic events at 28 days, mortality at 24 h and 28 days, number of intensive care unit-free days, number of ventilator-free days, number of hospital-free days within the first 28 days, hospitalization status at day 28, Glasgow outcome scale extended for patients with brain lesions on initial cerebral imaging, and cost of each strategy at days 8 and 28. Inclusions have started in December 2017 and are expected to be complete by June 2021.DiscussionIf PCC reduces total blood consumption at day 1 after severe trauma, this therapy, in adjunction to a classic massive transfusion protocol, may be used empirically on admission in patients at risk of massive transfusion to enhance coagulation. Moreover, this treatment may decrease blood product-related complications and may improve clinical outcomes after post-traumatic hemorrhage.Trial registrationClinicalTrials.govNCT03218722. Registered on July 14, 2017

01 Nov 2020·HämostaseologieQ4 · MEDICINE

Extended Half-Life Factor VIII/Factor IX Products: Assay Discrepancies and Implications for Hemophilia Management

Q4 · MEDICINE

Article

Author: Oldenburg, Johannes ; Goldmann, Georg ; Müller, Jens ; Marquardt, Natascha ; Pötzsch, Bernd

AbstractDue to structural differences between extended half-life (EHL) factor VIII (FVIII) or FIX products and equivalent plasma wild-type molecules used for assay calibration, reagent-dependent discrepancies during monitoring of FVIII- and FIX-replacement therapies with EHL products have been described. To assess the performance of available one-stage clotting and chromogenic substrate assays on the Siemens Atellica COAG 360 analyzer, an in vitro study using spiked plasma samples was performed. The described results confirm previously described findings and allowed allocation of each EHL product to an appropriate assay. In addition, corresponding EHL product–specific analytes were defined within the order entry system of the University Hospital Bonn. The requirement of product-specific FVIII and FIX assays complicates patient monitoring and demonstrates the need for both continuous education and communication between treating physicians and the coagulation laboratory.

100 Deals associated with Factor IX(Bio Products Laboratory)

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External Link

KEGG	Wiki	ATC	Drug Bank
D04123	Factor IX(Bio Products Laboratory)	B02BD04	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemophilia B	United Kingdom	Bio Products Laboratory USA, Inc.	09 Aug 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia B	Preclinical	Poland	Bio Products Laboratory USA, Inc.	01 Jul 1997

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASGCT2016	Not Applicable	Hemophilia B	-	Lentiviral Vectors Expressing Hyper-Functional Factor IX (Portal vein administration of LVs expressing canine FIX)	jwlargqoyj(yisudhxewu) = Intravenous LV administration was well tolerated with mild and self-limiting elevation of aminotransferases in one dog iglqrrvttv (jgofwviqym ) View more	-	01 May 2016
				Lentiviral Vectors Expressing Hyper-Functional Factor IX (Peripheral vein administration of LVs expressing hyperfunctional canine FIX)
ASGCT2010	Not Applicable	Hemophilia B	-	Factor IX-R338L (FIX Padua) (AAV6-cFIX-wt)	krethwaqgl(opxfwgrrqs) = scjwmdvcfd aqstyqwjsh (iuyutyihjp ) View more	-	01 May 2010
				Factor IX-R338L (FIX Padua) (AAV6-cFIX-Padua)	krethwaqgl(opxfwgrrqs) = yhlvdakalw aqstyqwjsh (iuyutyihjp ) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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