Delving into the Latest Updates on Antihemophilic factor/von Willebrand factor complex(Grifols SA) with Synapse

Overview

Basic Info

Drug Type

Non-recombinant coagulation factor

Synonyms

Alphanate, Factor VIII/von Willebrand factor, Fanhdi

+ [1]

Target

F10

Action

stimulants

Mechanism

F10 stimulants(Coagulation factor X stimulants), Blood coagulation pathway activation, Coagulation factor VIII replacements

+ [1]

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Factor 8 Deficiency, AcquiredHemophilia AVon Willebrand Diseases

Inactive Indication-

Originator Organization

Grifols SA

Active Organization

Grifols Biologicals, Inc.

Grifols SAAlpha Therapeutic Corp.

Inactive Organization

Grifols Therapeutics, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (15 Aug 1978),

Factor 8 Deficiency, AcquiredHemophilia AVon Willebrand Diseases

RegulationOrphan Drug (United States)

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This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with alphanate.
The study consists of 2 phases:
An ITI Treatment Phase in which all eligible participants will receive ITI treatment with alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, participants will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a participants has achieved partial immune tolerance, the participants will enter a 12-month Prophylactic Phase.
A 12-month Prophylactic Phase for all participants who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of alphanate. Due to limited enrollment, this study was early terminated.

Start Date03 Jan 2018

Sponsor / Collaborator

Grifols Therapeutics, Inc.

[+1]

CTRI/2017/04/008336

/ Active, not recruitingPhase 2

A Multicenter, Phase 2 Open-Label, Single-Arm, Prospective, InterventionalStudy of Plasma-Derived Factor VIII/VWF (AlphanateÃ?Â®) in Immune Tolerance InductionTherapy in Subjects with Congenital Hemophilia A and Inhibitors - Nil

Start Date02 May 2017

Sponsor / Collaborator-

EUCTR2012-003450-92-ES

/ Unknown statusNot Applicable

EVALUATION OF THE PHARMACOKINETIC PROFILE, CLINICAL EFFICACY AND SAFETY OF THE VON WILLEBRAND FACTOR CONTAINED IN FANHDI® (DOUBLE-INACTIVATED HUMAN ANTI-HEMOPHILIC FACTOR) IN PEDIATRIC PATIENTS WITH VON WILLEBRAND DISEASE - Study of Fanhdi® in pediatric patients with VWD

Start Date23 Nov 2013

Sponsor / Collaborator

Instituto Grifols SA

100 Clinical Results associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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100 Translational Medicine associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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100 Patents (Medical) associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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55

Literatures (Medical) associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

01 Jan 2024·Clinical and Applied Thrombosis/Hemostasis

Real-World Efficacy and Safety of Plasma-Derived Von Willebrand Factor-Containing Factor VIII Concentrates in Patients With Von Willebrand Disease in Italy

Article

Author: Pieri, Lisa ; Santoro, Cristina ; Borchiellini, Alessandra ; Barillari, Giovanni ; Santoro, Rita Carlotta ; Mir, Roser ; Federici, Augusto B. ; Tosetto, Alberto ; Zanon, Ezio ; Santi, Roberto Mario ; De Cristofaro, Raimondo ; Mairal, Esther

Plasma-derived von Willebrand factor-containing factor VIII concentrates (pd-VWF/FVIII-C) are the mainstay of treatment in von Willebrand disease (VWD). Real-world data on efficacy and safety of these pd-VWF/FVIII-C are required. To retrospectively evaluate the efficacy and safety of pd-VWF/FVIII-C (Fanhdi® and Alphanate®, Grifols) in clinical practice in Italy. A multicentric, observational, retrospective study at 10 Italian centers was conducted. Eligible patients diagnosed with inherited VWD (ISTH criteria) were treated with either Fanhdi® or Alphanate® for bleeding episodes, prevention of surgical bleeding and secondary long-term prophylaxis (SLTP) according to clinical practice with medical records collected from January 2007 to December 2019. Efficacy/safety of pd-VWF/FVIII-C was assessed according to FDA-agreed objective criteria following regulatory procedures. Fifty-seven patients (M/F: 21/36) were enrolled in the study with the following VWD types: VWD1 (n = 29, 52%), VWD2A (n = 10, 18%), VWD2B (n = 7, 12%), VWD2M (n = 2, 4%), VWD2N (n = 1, 2%), VWD2 unclassified (n = 1, 2%), and VWD3 (n = 7, 12%). These pd-VWF/FVIII-C were used to manage 58 bleeding episodes (n = 24 patients), 100 surgeries (n = 47 patients), and 7 SLTP (n = 6 patients). Global clinical efficacy with these pd-VWF/FVIII-C was reported to be excellent/good in 85% of bleeding episodes, 98% of surgeries, and 100% of SLTP. As far as safety, no adverse-drug-related episodes, immunogenic or thrombotic events were reported. This study confirmed that Fanhdi® and Alphanate® were effective and safe in the management of bleeding episodes, the prevention of bleeding during surgeries and for SLTP in Italian patients with inherited VWD.

13 Jun 2023·Cureus

Anesthetic Management Including Postoperative Regional Anesthesia in a Young Adult Patient With Von Willebrand Disease and Osteogenesis Imperfecta

Author: Crespo, Maria J ; Torres-Pérez, Hector ; Rosa-Carrasquillo, Cristian ; Rivera-Pérez, Dennys ; Reyes-Sullivan, Allan J

There are no established guidelines regarding anesthesia with a peripheral nerve block (PNB) in the young adult population with von Willebrand disease (vWD) type I. We present a case of a successful PNB outcome in a 20-year-old male patient with vWD type I, osteogenesis imperfecta (OI), and rheumatoid arthritis (RA) who underwent an intramedullary nailing surgery after suffering a left distal femur fracture secondary to a sports injury. Before the procedure, the patient was treated with HUMATE-P® [antihemophilic factor and von Willebrand factor (human)], ALPHANATE^® (antihemophilic factor/von Willebrand factor complex), and aminocaproic acid for hematologic control. Left femoral and popliteal nerve blocks were performed for postoperative pain control. The patient was discharged home uneventfully three days after the surgery. In this case, PNB proved to be a safe and effective alternative in the management of a vWD type I young adult patient with comorbidities. Given the lack of established guidelines, a multidisciplinary team should be involved in the pre and perioperative management of these patients due to the risk of delayed bleeding.

01 Jan 2022·Clinical and Applied Thrombosis/HemostasisQ4 · MEDICINE

Clinical Efficacy and Safety of Fanhdi^®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study

Q4 · MEDICINE

Article

Author: Jiménez-Yuste, Víctor ; Núñez, Ramiro ; Nieto Hernández, Maria del Mar ; Marzo Alonso, Cristina ; Varó Castro, Maria José ; Palomo Bravo, Ángeles ; Benítez Hidalgo, Olga ; Coll, Julia ; Galmes, Bernardo J. ; Alvarez-Román, María Teresa ; Mir, Roser ; Hernández García, Carmen ; Carrasco, Marina ; Pérez González, Noelia Florencia ; García Candel, Faustino ; Gonzalez-Porras, Jose Ramon

Objective To evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. Methods A retrospective, multicentric, observational study of VWD patients treated with Fanhdi®, a pdVWF/FVIII concentrate, from January 2011 to December 2017 was conducted at 14 centers in Spain. Efficacy and safety were evaluated for acute bleeding episodes, for prevention of bleeding in surgeries, and for secondary long-term prophylaxis. Results Seventy-two eligible patients, type 1, 2, 3 VWD (25%/38.9%/36.1%) were treated for spontaneous and traumatic bleeding (140 episodes, n = 41 patients), to prevent surgical bleeding (69 episodes, n = 43 patients); and for secondary long-term prophylaxis (18 programs, n = 13 patients). Replacement therapy with pdVWF/FVIII showed an excellent to good clinical efficacy in 96.7% of the bleeding episodes, 100% during surgical procedures and 100% during prophylaxis. No adverse events (AEs), nor serious AEs related to the product were observed. Conclusions Fanhdi® was effective, safe and well tolerated in the management of bleeding episodes, the prevention of bleeding during surgeries, and for secondary long-term prophylaxis in VWD patients.

100 Deals associated with Antihemophilic factor/von Willebrand factor complex(Grifols SA)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Antihemophilic factor/von Willebrand factor complex(Grifols SA)	B02BD06	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Factor 8 Deficiency, Acquired	United States	Grifols Biologicals, Inc.	15 Aug 1978
Hemophilia A	United States	Grifols Biologicals, Inc.	15 Aug 1978
Von Willebrand Diseases	United States	-	15 Aug 1978

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 2	Canada	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Spain	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 2	India	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Italy	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Canada	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 2	India	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Italy	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Russia	Grifols Biologicals, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Russia	Grifols Therapeutics, Inc.	03 Jan 2018
Hemophilia A	Phase 2	Spain	Grifols Biologicals, Inc.	03 Jan 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03095287 (CTgov)	Phase 2	Hemophilia A	2	Alphanate	fcsnragttx(dbpjowatvu) = mziolkgupu bbrjjxdixb (abnfowgfgo, sabiputgnp - verdugslrd) View more	-	23 Nov 2021
ISTH2020	Not Applicable	Von Willebrand Diseases	-	Fanhdi®	kfqwibbuvd(jqehgejstx) = qxsqqotjuw pvvbgwekkc (dtrmlbnltc ) View more	Positive	12 Jul 2020

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Biosimilar

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