Delving into the Latest Updates on Octocog alfa(Bayer AG) with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor, Biosimilar

Synonyms

Helixate FS, Kogenate FS, Octocog alfa

+ [16]

Target

F10

Mechanism

F10 stimulants(Coagulation factor X stimulants)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Hemophilia A

Inactive Indication-

Originator Organization

Bayer AG

Active Organization

Bayer AGBayer Healthcare LLC

Inactive Organization

Bayer Corp.

Drug Highest PhaseApproved

First Approval Date

EU (04 Aug 2000),

Hemophilia A

RegulationOrphan Drug (US), Priority Review (CN)

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Gene Sequence

Sequence Code 139887

The sequence is quoted from: *****

Sequence Code 1191632865

The sequence is quoted from: *****

The purpose of this study is to collect more information about the safety and efficacy of Kovaltry for the prevention and treatment of bleeding in Chinese children, adolescents, and adults with severe hemophilia A. In addition, the pharmacokinetic parameters of Kovaltry will be evaluated in a subset of patients.

Start Date22 Sep 2020

Sponsor / Collaborator

Bayer Healthcare Co., Ltd.

NCT04565236 / CompletedPhase 4

A Post Approval Commitment Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of KOVALTRY in Chinese Children, Adolescents /Adults With Severe Hemophilia A

The goal of this study is to gather more information on safety and efficacy of Kovaltry for the prevention and treatment of bleeds in Chinese children, adolescents/adults with severe hemophilia A. In addition, pharmacokinetic parameters of Kovaltry will be assessed in a subset of patients.

Start Date22 Sep 2020

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Octocog alfa(Bayer AG)

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100 Translational Medicine associated with Octocog alfa(Bayer AG)

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100 Patents (Medical) associated with Octocog alfa(Bayer AG)

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124

Literatures (Medical) associated with Octocog alfa(Bayer AG)

06 Nov 2024·Journal of Bone and Joint Surgery

No Discernible Difference in Revision Rate or Survivorship Between Posterior Cruciate-Retaining and Posterior Cruciate-Substituting TKA

Article

Author: Park, Jang-Won ; Kim, Young-Hoo ; Kim, Eun-Jung ; Jang, Young-Soo

Background:Many authors and the data of multiple registries have suggested that the use of posterior cruciate-substituting (posterior stabilized [PS]) total knee arthroplasty (TKA) leads to a higher risk of revision compared with the use of posterior cruciate-retaining (CR) TKA. The aim of the present prospective, randomized, long-term study was to compare PS and CR TKA with regard to the clinical, radiographic, and computed tomography (CT) results; the prevalence of osteolysis; revision rate; and survivorship.Methods:This study included a consecutive series of 300 patients (mean age [and standard deviation], 63.6 ± 6 years) who underwent simultaneous, bilateral TKA in the same anesthetic session. Each patient received a NexGen CR-Flex prosthesis on 1 side and a NexGen LPS-Flex prosthesis on the contralateral side. The mean follow-up period was 18 years (range, 17.5 to 19.5 years).Results:There were no significant differences between the NexGen CR and LPS-Flex TKA groups at the latest follow-up with regard to the mean Knee Society knee score (93 versus 92 points, respectively); the Western Ontario and McMaster Universities Osteoarthritis Index score (19.1 points for both); the University of California Los Angeles activity score (6.1 points for both); range of motion (125° ± 6.1° versus 126° ± 6.5°); radiographic and CT results; and revision rate (6.0% versus 6.3%). No knee had osteolysis. The estimated survival rate at 19.5 years was 94% (95% confidence interval [CI], 91% to 100%) for the NexGen CR-Flex prosthesis and 93.7% (95% CI, 91% to 100%) for the LPS-Flex prosthesis, with revision or aseptic loosening as the end point.Conclusions:The findings of the present, long-term (minimum follow-up of 17.5 years) clinical study showed that NexGen CR-Flex and NexGen LPS-Flex implants produced excellent clinical and radiographic results. There was no notable clinical advantage of a NexGen CR-Flex implant over a NexGen LPS-Flex implant.Level of Evidence:Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

01 Sep 2024·Drugs in R&D

Damoctocog Alfa Pegol, a PEGylated B-domain Deleted Recombinant Extended Half-life Factor VIII for the Treatment of Hemophilia A: A Product Review

Review

Author: Poulsen, Lone H ; Shah, Anita ; Solms, Alexander ; Ducore, Jonathan ; Simpson, Mindy ; Meijer, Karina ; Kenet, Gili ; Lalezari, Shadan ; Holme, Pål André ; Di Minno, Giovanni ; Reding, Mark T ; Mancuso, Maria Elisa

Damoctocog alfa pegol (BAY 94-9027, Jivi^®), is a site-specifically PEGylated, extended half-life recombinant factor VIII (FVIII) that is approved in several European and non-European countries for on-demand treatment and prophylaxis of bleeding in previously treated patients aged ≥ 12 years with hemophilia A. Reliable measurements can be obtained using most one-stage and chromogenic FVIII assays over a wide concentration range. The efficacy, safety and pharmacokinetics (PK) of damoctocog alfa pegol have been studied extensively in the PROTECT VIII clinical trials, and its long-term safety and effectiveness profile is continuing to build through observational and interventional real-world studies. The PK of damoctocog alfa pegol was shown to be improved as compared with that of sucrose-formulated rFVIII (rFVIII-FS, Kogenate^®), and was also demonstrated to be non-inferior to and, for some variables, more favorable than rFVIII-Fc fusion protein, efmoroctocog alfa (Elocta^®; NCT03364998), rurioctocog alfa pegol (BAX 855, Adynovate^®/Adynovi^®; NCT04015492), and antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM, Advate^®; NCT02483208). Damoctocog alfa pegol was generally well tolerated and none of the patients in any of the clinical trials, including the PROTECT VIII clinical program, HEM-POWR, or ongoing single-center studies, developed FVIII inhibitors. Efficacy for perioperative hemostasis has been demonstrated. Low bleeding rates were achieved across the studies, with twice weekly, every 5-day and every 7-day prophylaxis offering patients ≥ 12 years and their clinicians the chance to tailor treatment to individual needs and lifestyles, while maintaining long-term protection from bleeds and their consequences.

01 Jul 2024·Journal of Thrombosis and Haemostasis

Development of a rapid and fully automated factor VIII inhibitor assay, insensitive to emicizumab, and a lowest level of quantification of 0.2 BU/mL

Article

Author: Verbruggen, Bert ; Binder, Nikolaus B ; Sobas, Frédéric ; Moore, Gary W ; Polenewen, Robert ; van Velp, Petra J C ; Knöbl, Paul

BACKGROUNDFactor (F)VIII inhibitors are measured using labor- and resource-expensive Nijmegen or Bethesda assays, which lack sensitivity for low-titer inhibitors and show high variations in quality surveys, mainly because of manual assay procedures.OBJECTIVESThe goal of this study was the development of a fast and fully automated FVIII inhibitor assay by using recombinant (r)FVIII as substrate and dedicated equipment for execution of the test.METHODSA new rapid, fully automated, FVIII inhibitor assay is presented, the core of which is use of full-length recombinant FVIII (rFVIII; Kovaltry, Bayer) as inhibitor substrate instead of plasma FVIII, resulting in rapid binding of inhibitors to rFVIII due to absence of von Willebrand factor. Dramatic shortening of incubation time facilitated full automation on an analyzer capable of 3 subsequent sample dilution steps and 3 reagent additions. Equal volume mixtures of sample and rFVIII (1.0 U/mL) were incubated for 10 minutes at 37 °C, whereafter remaining FVIII activity was analyzed with a kinetic chromogenic assay, allowing inhibitor activity calculation without preceding FVIII activity calibration, using a Ceveron s100 analyzer (Technoclone).RESULTSMean titer in 60 nonhemophiliacs was 0.0 BU/mL (SD, 0.1), yielding a limit of blank of 0.1 BU/mL and lower limit of quantification of 0.2 BU/mL. Analyses were performed with the new method and a Nijmegen assay in 28 inhibitor-positive clinical samples, 14 containing emicizumab and 14 without. Correlation coefficient in emicizumab-free type I inhibitor samples was 1.0. Emicizumab dependency of the method was excluded in spiking experiments with inhibitor-positive samples. Reproducibility was tested by analyzing 7 samples in 3 laboratories for 5 days, twice daily; coefficients of variation of all samples were <15%.CONCLUSIONWe present development data of a sensitive and specific rapid, automated FVIII inhibitor assay generating results within 20 minutes that is less resource-intensive than standard assays with potential to improve assay variability.

100 Deals associated with Octocog alfa(Bayer AG)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	B02BD02	DB00025

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemophilia A	NO	Bayer AG	04 Aug 2000
Hemophilia A	IS	Bayer AG	04 Aug 2000
Hemophilia A	LI	Bayer AG	04 Aug 2000
Hemophilia A	EU	Bayer AG	04 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Discovery	US	Bayer Corp.	20 Aug 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2023	Not Applicable	Hemophilia A	-	BAY 94-9027	augpkaldsa(oyqkyhyhcn) = xydyatawuy xkbouqagdk (xveibntliw )	Positive	24 Jun 2023
				BAY 81-8973	augpkaldsa(oyqkyhyhcn) = qtmdpbbywt xkbouqagdk (xveibntliw )
NCT02830477 (TAURUS, Pubmed) Manual	Phase 4	Hemophilia A	302	BAY 81-8973	(paqsqxmcut) = tremained stable during observation period bfgvqjzfyt (hkiqplvmqa ) View more	Positive	03 Oct 2022
ISTH2022	Not Applicable	Hemophilia	-	Kogenate FS	(gwwdbrbcwm) = ucbiwcxbiu lsdjapopck (efjdpsmorc ) View more	-	09 Jul 2022
				Advate	(gwwdbrbcwm) = rlbmvxqyya lsdjapopck (efjdpsmorc ) View more
NCT02483208 (Pubmed \| Clin Pharmacokinet)	Phase 1	Hemophilia A	18	BAY 81-8973	ytngxsbbmw(oreywyvoat) = vzrvjtdgpe ayadhponmc (npovkabedy ) View more	-	01 Sep 2017
				Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method (rAHF-PFM)	ytngxsbbmw(oreywyvoat) = pjyfqvvgwt ayadhponmc (npovkabedy ) View more
NCT01311648 (Pubmed \| Protein Expr Purif)	Phase 3	Hemophilia A	94	BAY 81-8973	(trfqqsfhum) = During BAY 81-8973 treatment, 5% of patients had sporadic increases in anti-HSP70 antibody levels above a predefined threshold (cutoff value, 239 ng/mL). No clinical symptoms related to anti-HSP70 antibody development occurred. udugwrhfii (pxuvuwcake )	-	01 Nov 2016
NCT01029340 \| NCT01233258 (LEOPOLD I, LEOPOLD II, Pubmed \| J Thromb Haemost)	Phase 3	Hemophilia A	121	BAY 81-8973 (Chromogenic assay)	ktdntstuqo(ubygjcjgvo) = suppxrooqh hrwacphthk (rpoqwmdaxu )	-	01 Jun 2016
				BAY 81-8973 (One-stage assay)	ktdntstuqo(ubygjcjgvo) = nsygbiuiar hrwacphthk (rpoqwmdaxu )
NCT01311648 (LEOPOLD Kids, Pubmed \| Haemophilia) Manual	Phase 3	Hemophilia A	51	BAY 81-8973	(eryklpjdoz) = gucikzxdct uwwlnrunhq (yjfwgcknww ) View more	Positive	01 May 2016
NCT01029340 \| NCT01311648 \| NCT01233258 (LEOPOLD, Pubmed \| Haemophilia)	Phase 3	Hemophilia A	-	BAY 81-8973	(jrpegkiozn) = Blood loss during surgery did not exceed expected amounts ppofyitlwp (uhkjlolfqu ) View more	-	01 May 2016
NCT01184820 (Pubmed \| J Thromb Haemost)	Phase 1	Hemophilia A	14	BAY 94-9027	hrljbbskki(dddwcpiifd) = uarssutswx zjzufszaxm (wlyuagqczw )	-	01 Apr 2014
				sucrose-formulated rFVIII (rFVIII-FS)	hrljbbskki(dddwcpiifd) = mncmhyuash zjzufszaxm (wlyuagqczw )