- |||||||||| Alhemo (concizumab) / Novo Nordisk
Journal: Concizumab improves clot formation in hemophilia A under flow. (Pubmed Central) - Aug 22, 2024 Our results demonstrate the potential of concizumab for subcutaneous prophylaxis in GT patients. TFPI inhibition by concizumab enhanced activation and aggregation of platelets and fibrin clot formation in hemophilia A to levels comparable with that of rFVIIa.
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P3 data, Journal, Patient reported outcomes: Concizumab prophylaxis in persons with hemophilia A or B with inhibitors: patient-reported outcome results from the phase 3 explorer7 study. (Pubmed Central) - Aug 5, 2024 P3 The majority of patients receiving concizumab expressed a preference for concizumab over their previous treatment, the main reasons being "fewer bleeds," "require less time," and "less painful to inject." Across all PROs, there were less responses collected than anticipated, limiting interpretations. PROs collected during the explorer7 study showed improvements in some domains of HRQoL, treatment burden, and patient treatment preference in persons with hemophilia A or B with inhibitors receiving concizumab prophylaxis compared with no prophylaxis.
- |||||||||| Hemlibra (emicizumab-kxwh) / Roche, Alhemo (concizumab) / Novo Nordisk
Observational data, Journal: Disease and treatment burden of patients with haemophilia entering the explorer6 non-interventional study. (Pubmed Central) - Jul 20, 2024 Despite receiving routine clinical care, historical and baseline information from patients enrolled in explorer6 showed that patients with HA/HB treated episodically and patients with HAwI/HBwI had higher ABRs, higher treatment burden and participated in sports less than those with HA/HB treated with prophylaxis. Emerging treatments could be beneficial in addressing these unmet medical needs.
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Daily difference: Patient and physician experience with Alhemo (Presentation Theater #2) - May 18, 2024 - Abstract #ISTH2024ISTH_2438; The presence of concizumab did not, or only slightly, influence the outcome of standard clinical coagulation assays relevant for HA and HB. Sponsored by Novo Nordisk Healthcare AG
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Management of breakthrough bleeding episodes in the phase 3 concizumab studies (Plenary Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_2050; P3 Most BTBs of mild/moderate severity were treated with one injection of the respective BTB treatment (Table 2). In people with HAwI/HBwI, bleeds were most often managed with recombinant activated factor VII (median consumption per injection: mild/moderate bleeds in HAwI 90.0
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Enrollment open: NN7415-7557: Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo (clinicaltrials.gov) - Apr 1, 2024 P=N/A, N=23, Enrolling by invitation, With the advent of novel therapeutic agents including factor concentrates with ultra-long half-life and improved FVIIIa mimetics aimed at raising the bar of protection into the non-hemophilic range redefinition of haemophilia treatment goals is eagerly needed. Not yet recruiting --> Enrolling by invitation
- |||||||||| Review, Journal: Non-clotting factor therapies for preventing bleeds in people with congenital hemophilia A or B. (Pubmed Central) - Feb 27, 2024
Evidence from RCTs shows that prophylaxis using non-clotting factor therapies compared with on-demand treatment may reduce bleeding events, increase the percentage of individuals with zero bleeds, increase the incidence of non-serious adverse events, and improve HRQoL. Comparative assessments with other prophylaxis regimens, assessment of long-term joint outcomes, and assessment of economic outcomes will improve evidence-based decision-making for the use of these therapies in bleed prevention.
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Journal: Angiology and hemostasis: what's new in 2023 (Pubmed Central) - Jan 17, 2024 Concizumab, an antibody targeting the tissue factor pathway inhibitor, broadens the therapeutic arsenal for hemophilia A and B as evidenced by the results of the EXPLORER 7 study. The PREVENT-CLOT and CASTING study focus on the prevention of thrombosis after trauma, by testing the role of aspirin or the lack of thromboprophylaxis, respectively.
- |||||||||| Journal: Antibodies to watch in 2024. (Pubmed Central) - Jan 9, 2024
In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.
- |||||||||| Alhemo (concizumab) / Novo Nordisk
P3 data, Journal: Phase 3 Trial of Concizumab in Hemophilia with Inhibitors. (Pubmed Central) - Sep 3, 2023 P3 Among patients with hemophilia A or B with inhibitors, the annualized bleeding rate was lower with concizumab prophylaxis than with no prophylaxis. (Funded by Novo Nordisk; explorer7 ClinicalTrials.gov number, NCT04083781.).
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Review, Journal: Concizumab: First Approval. (Pubmed Central) - Jun 21, 2023 In March 2023, concizumab was approved in Canada for the treatment of adolescent and adult patients (12 years of age or older) with hemophilia B who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes. This article summarizes the milestones in the development of concizumab leading to this first approval for the treatment of hemophilia B.
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Evaluation of Concizumab in Hemophilia Using Microfluidic Flow Assays (Room:517) - May 18, 2023 - Abstract #ISTH2023ISTH_2223; Trial completion date: Dec 2025 --> Jun 2026 Learning Objectives: Upon completion, participant will be able to consider the effect of flow on the efficacy of anti-TFPI therapeutic concizumab.Upon completion, participant will be able to describe the flow circuit for a microfluidic assay that reintroduces calcium to study coagulation in vitro.Upon completion, participant will be able to consider the applicability of a flow-based assay to their work.
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Health-related quality of life, treatment burden and patient preference in patients with haemophilia A/B without inhibitors on concizumab prophylaxis: results from the phase 3 explorer8 study (Room:517) - May 18, 2023 - Abstract #ISTH2023ISTH_2222; Learning Objectives: Upon completion, participant will be able to consider the effect of flow on the efficacy of anti-TFPI therapeutic concizumab.Upon completion, participant will be able to describe the flow circuit for a microfluidic assay that reintroduces calcium to study coagulation in vitro.Upon completion, participant will be able to consider the applicability of a flow-based assay to their work. Learning Objectives: Upon completion, participant will be able to review the patient-reported outcome data collected in the phase 3 explorer8 study in patients with haemophilia A or B without inhibitors.Upon completion, participant will be able to understand the supporting evidence for improved health-related quality of life, reduction in treatment burden and patient preference in patients receiving once-daily, subcutaneous concizumab prophylaxis.Upon completion, participant will be able to examine the limitations associated with the patient-reported outcome data.
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Pooled Safety Results from the Multidose explorer Studies of Concizumab in Patients with Haemophilia (Room:517) - May 18, 2023 - Abstract #ISTH2023ISTH_2221; Learning Objectives: Upon completion, participant will be able to review the patient-reported outcome data collected in the phase 3 explorer8 study in patients with haemophilia A or B without inhibitors.Upon completion, participant will be able to understand the supporting evidence for improved health-related quality of life, reduction in treatment burden and patient preference in patients receiving once-daily, subcutaneous concizumab prophylaxis.Upon completion, participant will be able to examine the limitations associated with the patient-reported outcome data. Learning Objectives: have an overview of the pooled safety data from multiple-dose studies in the
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Analyzing Concizumab mechanism of action by a Mathematical Modeling Approach (Room:517) - May 18, 2023 - Abstract #ISTH2023ISTH_2220; and TFPI? Describe a mathematical modeling approach to study the downstream effects of TFPI inhibition by concizumab on thrombin generation under flowExplain how the effectiveness of concizumab is due to its blocking multiple inhibitory mechanisms of TFPI?.
- |||||||||| Alhemo (concizumab) / Novo Nordisk
Concizumab prophylaxis in patients with haemophilia A or B without inhibitors: Efficacy and safety results from the primary analysis of the phase 3 explorer8 study (Room:517) - May 18, 2023 - Abstract #ISTH2023ISTH_2219; Describe a mathematical modeling approach to study the downstream effects of TFPI inhibition by concizumab on thrombin generation under flowExplain how the effectiveness of concizumab is due to its blocking multiple inhibitory mechanisms of TFPI?. Learning Objectives: Summarise data showing that concizumab prophylaxis was effective in reducing the annualised bleeding rate compared with no prophylaxis in patients with haemophilia A and B without inhibitors.Acknowledge that concizumab prophylaxis was considered safe and well-tolerated in patients with haemophilia A and B.Understand that concizumab has the potential to be the first subcutaneous treatment option for haemophilia B given the confirmed superiority of concizumab prophylaxis compared with no prophylaxis in phase 3 clinical studies.
- |||||||||| concizumab (NN7415) / Novo Nordisk, NovoSeven (eptacog alfa) / Novo Nordisk
TFPI INHIBITION MIGHT BE USEFUL FOR THE TREATMENT OF UNDIAGNOSED BLEEDING DISORDERS () - Feb 13, 2023 - Abstract #EAHAD2023EAHAD_472; Learning Objectives: Summarise data showing that concizumab prophylaxis was effective in reducing the annualised bleeding rate compared with no prophylaxis in patients with haemophilia A and B without inhibitors.Acknowledge that concizumab prophylaxis was considered safe and well-tolerated in patients with haemophilia A and B.Understand that concizumab has the potential to be the first subcutaneous treatment option for haemophilia B given the confirmed superiority of concizumab prophylaxis compared with no prophylaxis in phase 3 clinical studies. TFPI activity and antigen plasma level were measured in citrated plasma with ACTICHROME
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