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14 Diseases |  |
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6 Trials |  |
245 News |  |
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- | Alhemo (concizumab) / Novo Nordisk
Trial completion date, Trial primary completion date: In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients (clinicaltrials.gov) - Dec 14, 2022
P=N/A, N=20, Recruiting, Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Trial completion date: Sep 2023 --> Dec 2023 | Trial primary completion date: Sep 2023 --> Dec 2023
- || Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: The Implication of New Developments in Hemophilia Treatment on Its Laboratory Evaluation. (Pubmed Central) - Nov 18, 2022
For measuring modified long-acting coagulation factors, chromogenic assays will be probably more suitable than one-stage clotting assays. Novel drugs that are not based on coagulation factors, such as emicizumab, fitusiran, or concizumab, will require alternative methods.
- | Alhemo (concizumab) / Novo Nordisk
New trial: In Vitro Correction of Thrombin Generation by Concizumab (Anti-TFPI) for Severe Hemophilia Patients (clinicaltrials.gov) - Nov 15, 2022
P=N/A, N=20, Recruiting, Sponsor: Centre Hospitalier Universitaire de Saint Etienne
- concizumab (NN7415) / Novo Nordisk
Active Lifestyle in Patients with Hemophilia A or B with Inhibitors on Once-Daily Subcutaneous Concizumab Prophylaxis: Results from the Phase 3 explorer7 Study (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3901;
P=N/A, P3
While the results should be interpreted with caution due to the smaller cohort of patients included in the current exploratory analysis, prophylactic treatments such as concizumab could encourage patients to spend more time engaging in physical activity that is also of appropriate (higher) risk, which could in turn improve their muscle strength and joint health. Changes in physical activity were also investigated in hemophilia patients without inhibitors in explorer8 phase 3 study.
- concizumab (NN7415) / Novo Nordisk
Treatment Burden and Patient Preference in Patients with Hemophilia A or B with Inhibitors on Concizumab Prophylaxis: Results from the Phase 3 explorer7 Study (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3881;
P3
For the Hemo-TEM total score, the estimated treatment difference between concizumab and no-prophylaxis arms was statistically significant. Most patients who responded to the H-PPQ questionnaire preferred concizumab prophylaxis over their previous treatment.
- concizumab (NN7415) / Novo Nordisk
Health-Related Quality of Life in Patients with Hemophilia A or B with Inhibitors on Concizumab Prophylaxis: Results from the Phase 3 explorer7 Study (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_1980;
P3
The differences were mostly in favor of concizumab, with the largest ETDs being related to mental and general health. SF-36v2 and Haem-A-QoL are being investigated as part of the explorer8 concizumab phase 3 study in patients with hemophilia A or B without inhibitors.
- concizumab (NN7415) / Novo Nordisk
Subcutaneous Concizumab Prophylaxis in Patients with Hemophilia A or B with Inhibitors: Efficacy and Safety Results By Hemophilia Subtype from the Phase 3 Explorer7 Trial (ENMCC - 288-290) - Nov 4, 2022 - Abstract #ASH2022ASH_1587;
P3
The overall median ABR was 0.0 across both hemophilia subtypes. Concizumab was considered safe and well tolerated in patients with HAwI and HBwI with no thromboembolic events reported after treatment restart.
- || Alhemo (concizumab) / Novo Nordisk
Trial completion date: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - Oct 28, 2022
P3, N=136, Active, not recruiting, Sponsor: Novo Nordisk A/S
Concizumab was considered safe and well tolerated in patients with HAwI and HBwI with no thromboembolic events reported after treatment restart. Trial completion date: Jun 2024 --> Dec 2025
- SUBCUTANEOUS TREATMENT MODALITIES IN HEMOPHILIA CARE IN 2022 () - Oct 16, 2022 - Abstract #EHOC2022EHOC_55;
These therapies are all designed to be given subcutaneously and at relatively infrequent intervals and thus reducing the treatment burden. The aim of our presentation is to shed the light on different families of "non-factor therapies": bispecific monoclonal antibody like emicizumab (approved and available to clinicians for the subcutaneous treatment of hemophilia A) and MIM8 (under investigation), rebalancing agents like fitusiran (an antithrombin inhibitor) and the anti-TFPI (Tissue Factor Pathway Inhibitor) antibodies, as marstacimab or concizumab.
- || Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: Non-factor therapies for bleeding disorders: A primer for the general haematologist. (Pubmed Central) - Sep 3, 2022
We review the available trial data, unanswered questions and challenges associated with these new treatment modalities. Finally, we provide practical management algorithms to aid the general haematologist when faced with a patient receiving emicizumab who requires surgery or may develop bleeding.
- || Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: Progress of Non-Factor Products in Hemophilia Treatment--Review (Pubmed Central) - Aug 28, 2022
The emergence of non-factor therapy brings new hope for the treatment of patients with inhibitor. Non-factor products mainly achieve therapeutic purpose by imitating the function of coagulation factor Ⅷ, inhibiting the function of anti-tissue factor pathway inhibitors, the expression of antithrombin mRNA, and the function of activated protein C. This paper reviews the latest research progress of non-factor products in the treatment of hemophilia.
- || Review, Journal, IO biomarker: The Vascular Endothelium and Coagulation: Homeostasis, Disease, and Treatment, with a Focus on the Von Willebrand Factor and Factors VIII and V. (Pubmed Central) - Aug 22, 2022
Monoclonal-antibody-based anti-vWF immunotherapy (caplacizumab) is used in the context of severe thrombophilia, regardless of the cause of the disorder. In cases of disseminated intravascular coagulation, the treatment of choice consists in administration of antifibrinolytics, all-trans-retinoic acid, and recombinant soluble human thrombomodulin.
- || concizumab (NN7415) / Novo Nordisk
@novonordisk presenta nuevos datos de concizumab / #Hemofilia / via @ActaSanitaria https://t.co/0MMhTiAaGK (Twitter) - Jul 30, 2022
- || Review, Journal: Current and future therapies for haemophilia-Beyond factor replacement therapies. (Pubmed Central) - Jul 27, 2022
Furthermore, monitoring of the haemostatic function of these products with concomitant therapy is also required in clinical practice. These products have promising haemostatic efficiency, but wider clinical experience is needed to provide optimal therapeutic strategies in the future.
- concizumab (NN7415) / Novo Nordisk
Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors: Efficacy and Safety Results From the Primary Analysis of the Phase 3 explorer7 Trial (ICC Auditorium) - Jun 25, 2022 - Abstract #ISTH2022ISTH_2709;
P3
Estimated mean annualised bleeding rate (ABR) was 1.7 (95% CI, 1.0–2.9) for concizumab versus 11.8 (95% CI, 7.0–19.9) for no prophylaxis (ABR ratio, 0.14 [95% CI, 0.07–0.29]; P< 0.001). Median ABR on concizumab was 0 ( Figure 1).
- | concizumab (NN7415) / Novo Nordisk
Journal: Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. (Pubmed Central) - Jun 11, 2022
P2
Ongoing phase 3 trials will further evaluate concizumab as a once-daily, subcutaneous treatment across hemophilia subtypes. Trials registered at www.clinicaltrials.gov (NCT03196284; NCT03196297).
- || Alhemo (concizumab) / Novo Nordisk
Trial completion date: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Jun 8, 2022
P3, N=158, Active, not recruiting, Sponsor: Novo Nordisk A/S
Trials registered at www.clinicaltrials.gov (NCT03196284; NCT03196297). Trial completion date: Dec 2024 --> Dec 2025
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Journal: Managing invasive procedures in haemophilia patients with limited resources, extended half-life concentrates or non-replacement therapies in 2022. (Pubmed Central) - May 15, 2022
No thrombotic complications have been reported in the surgical setting so far. A multidisciplinary team/facility remains crucial to manage major surgery in patients on prophylaxis with these new agents.
- Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk
Unmet Medical Needs in Patient-Reported Outcomes and Sports Activity in People with Haemophilia A/B with or without Inhibitors: Historical Data from Patients Entering a Non-Interventional Study (ExCel Center, S11A) - May 13, 2022 - Abstract #ISTH2022ISTH_2545;
P=N/A
Mean Hemo-TEM total scores [standard deviations] tended to be higher in patients without inhibitors treated episodically (HA: 36.1 [30.2]; HB: 28.5 [14.2]) than patients treated with prophylaxis (PPX; HA: 20.9 [14.9]; HB: 16.2 [11.9]). SF-36v2 summary scores were lowest in patients with inhibitors and/or treated episodically (Figure 1).
- Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Real-World Unmet Needs of Patients with Haemophilia A/B with or without Inhibitors: Historical Haemophilia Characteristics from Patients Entering a Non-Interventional Study (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_2234;
P=N/A
Median age was 28 years (range, 12–78 years). For the prophylaxis (PPX) group, the mean (median) annualised bleeding rates (ABR) for patients without inhibitors were HA 6.6 (2.0), HB 5.4 (2.0); and for patients with inhibitors HA 22.0 (9.0), HB 18.0 (10.0).
- glycopegylated turoctocog alfa pegol (NN7170) / Novo Nordisk, concizumab (NN7415) / Novo Nordisk
Validation of the Hemophilia Treatment Experience Measure (Hemo-TEM): a New Haemophilia-specific Patient-reported Outcome Measure (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1655;
Factor analysis generated 5 domains in the Hemo-TEM [injection difficulties (3 items), physical impact (6 items), treatment bother (7 items), interference with daily life (4 items), and emotional impact (6 items)] and a total score. All scores were reliable [internally consistent (0.84 to 0.88) and reproducible (0.80 to 0.92)].
- concizumab (NN7415) / Novo Nordisk
Treatment Experience in Hemophilia Patients With and Without Inhibitors on Concizumab Prophylaxis: Hemo-TEM results from the phase 2 explorer4 & 5 studies (ExCel Center, ICC Auditorium) - May 13, 2022 - Abstract #ISTH2022ISTH_1634;
P2
In explorer4, mean baseline Hemo-TEM total scores were similar between concizumab (25.0) and on-demand arms (26.2). After 24 weeks of treatment, the concizumab arm demonstrated change from baseline in mean Hemo-TEM total score of -15.3, indicating lower treatment burden versus baseline, with no change in the on-demand arm (Table 1).
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment open: Explorer10: A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors (clinicaltrials.gov) - Apr 28, 2022
P3, N=90, Recruiting, Sponsor: Novo Nordisk A/S
After 24 weeks of treatment, the concizumab arm demonstrated change from baseline in mean Hemo-TEM total score of -15.3, indicating lower treatment burden versus baseline, with no change in the on-demand arm (Table 1). Not yet recruiting --> Recruiting
- || concizumab (NN7415) / Novo Nordisk
Review, Journal: Concizumab as a Subcutaneous Prophylactic Treatment Option for Patients with Hemophilia A or B: A Review of the Evidence and Patient's Perspectives. (Pubmed Central) - Apr 26, 2022
Concizumab may represent a new opportunity for the treatment of persons with hemophilia, so there is much anticipation for the results of the ongoing trials still. This review retraces all the studies on concizumab published to date, with a brief discussion about the patient' perspectives.
- || Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk
Review, Journal: Thrombin generation for monitoring hemostatic therapy in hemophilia A: a narrative review. (Pubmed Central) - Apr 23, 2022
In addition, TGAs offer the opportunity to determine the response to bypassing agents (BPAs) and treatment with non-factor replacement therapy, where FVIII activity assays are not suitable for monitoring. This review summarizes the current knowledge about monitoring different HA treatment modalities by TGA, as single treatment option and when used in a concomitant fashion.
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Journal: Monitoring of new therapies for hemophilia. (Pubmed Central) - Feb 4, 2022
So far, laboratory monitorization has not been an obligate condition for the use of these novel therapies, though in some cases like their combination with bypassing agents to control breakthrough/surgical bleeds may seek for laboratory assays to ensure a well tolerated and effective utilization withing these special scenarios. In the next pages, application of global coagulation assays, for example, thrombinography or rotational thrombelastography will be referred looking to the works of some groups from around the world including our own experience.
- concizumab (NN7415) / Novo Nordisk
SURGERIES AND DIAGNOSTIC PROCEDURES IN HAEMOPHILIA PATIENTS ON CONCIZUMAB PROPHYLAXIS IN PHASE 2 CLINICAL TRIALS ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_315;
P2
A wide range of surgeries was conducted. While the number of surgery-related bleeds was low, and most were classified as mild/moderate, there was 1 severe bleeding episode.
- concizumab (NN7415) / Novo Nordisk
MINOR SURGERIES IN PATIENTS RECEIVING PROPHYLAXIS WITH CONCIZUMAB: EXPERIENCE IN OUR CENTER ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_282;
P2, P3
Rurioctocog alfa pegol (Adynovate®) 20 IU/kg was administered one hour before surgery and was repeated at 24 and 48 hours, maintaining the daily prophylaxis with concizumab. Our data indicate that concizumab combined with low-dose FVIII is effective and offers a good safety profile for controlling bleeding in patients with severe HA subjected to prophylaxis with concizumab and undergoing minor surgery.
- concizumab (NN7415) / Novo Nordisk
MANAGEMENT OF BREAKTHROUGH BLEEDS DURING CONCIZUMAB PROPHYLAXIS IN PATIENTS WITH HAEMOPHILIA A/B WITH AND WITHOUT INHIBITORS IN PHASE 3 CLINICAL TRIALS ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_278;
Our data indicate that concizumab combined with low-dose FVIII is effective and offers a good safety profile for controlling bleeding in patients with severe HA subjected to prophylaxis with concizumab and undergoing minor surgery. A risk mitigation strategy, BTB management guidance and an additional new dosing regimen, were developed and implemented to ensure patient safety across all haemophilia subtypes during the re-initiated phase 3 clinical trials.
- concizumab (NN7415) / Novo Nordisk
DOSE OPTIMISATION AND RISK MITIGATION DURING CONCIZUMAB PROPHYLAXIS IN PATIENTS WITH HAEMOPHILIA A/B WITH AND WITHOUT INHIBITORS IN PHASE 3 CLINICAL TRIALS ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_195;
For the re-initiation of concizumab phase 3 clinical trials, a risk mitigation strategy that additionally included a new dosing regimen with a dose adjustment based on concizumab exposure was established. The strategy also included guidance on breakthrough bleed management.
- Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
THROMBOSIS AND THE NOVEL HAEMOPHILIA THERAPIES ([VIRTUAL]) - Jan 28, 2022 - Abstract #EAHAD2022EAHAD_100;
These events remind us that there is not currently a solid conceptual framework for predicting such events, or understanding how to use the novel products in concert with other agents. I will highlight potential mechanisms of thrombosis in these settings and areas where additional research is needed.
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment closed: explorer8: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (clinicaltrials.gov) - Jan 24, 2022
P3, N=158, Active, not recruiting, Sponsor: Novo Nordisk A/S
I will highlight potential mechanisms of thrombosis in these settings and areas where additional research is needed. Recruiting --> Active, not recruiting
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Journal: Understanding the evolution of coverage policies for prophylaxis treatments of hemophilia A without inhibitors: a payer Delphi panel. (Pubmed Central) - Nov 29, 2021
Graf, Tuly, Harley, and Pednekar are employees of PRECISIONheor, a research consultancy to the health and life sciences industries that was contracted by Takeda to conduct this study and write the manuscript. Batt served as a consultant on this project through PRECISIONheor.
- |||||||| Alhemo (concizumab) / Novo Nordisk
New P3 trial: Explorer10: A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors (clinicaltrials.gov) - Nov 25, 2021
P3, N=90, Not yet recruiting, Sponsor: Novo Nordisk A/S
- concizumab (NN7415) / Novo Nordisk, NovoSeven (eptacog alfa) / Novo Nordisk
Laboratory Characterization of Unclassified Bleeding Disorders By Non-Conventional Tests () - Nov 24, 2021 - Abstract #ASH2021ASH_6270;
So, a single laboratory test to make a correct diagnosis of this pathology cannot be recommended. In accordance with this fact, a personalized treatment should be applied for each patient.
- || Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Review, Journal: Advances in the management of haemophilia: emerging treatments and their mechanisms. (Pubmed Central) - Nov 24, 2021
These therapies carry the potential of revolutionising haemophilia treatment by alleviating the current challenges presented by mainstay factor replacement. This review will provide an overview of the key trial findings related to novel therapies based on the mechanisms described above.
- ||| Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk
Review, Journal, Adverse events: Post-authorization pharmacovigilance for hemophilia in Europe and the USA: Independence and transparency are keys. (Pubmed Central) - Nov 21, 2021
This challenge is relevant for hemophilia drugs, after recent advances offered innovative replacement and non-replacement medicines that warrant monitoring due to the occurrence of predicted but also unexpected and rare ADRs. This article contains an overview of pharmacovigilance systems in the European Union and USA, describing the main ADRs related to traditional and recently available hemophilia medications and suggests how to involve stakeholders other than marketing authorization holders for an independent and transparent pharmacovigilance targeted to detect not only early ADRs but also those emerging post-marketing.
- concizumab (NN7415) / Novo Nordisk
Evaluation of Global Coagulation Tests for Monitoring Bleeding Phenotypes and Response to Treatments in FVII Deficiency (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2594;
These assays may allow to monitoring more personalized treatments to these patients. The results also pointed to the possibility that inhibition of TFPI might be useful for treatment of patients with FVII deficiency, opening the idea of its usage especially as an alternative therapy for patients with inhibitors.
- concizumab (NN7415) / Novo Nordisk
Improvement in Health-Related Quality of Life Measures after Long-Term, Daily, Subcutaneous Concizumab Prophylaxis in Patients with Hemophilia A/B with and without Inhibitors: Results from the Main and Extension Parts of Phase 2 Clinical Trials (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2589;
P2
Interestingly, PCS improvement was observed across all hemophilia subgroups, suggesting better functional health, albeit the large standard deviation reported. The potential beneficial effect of concizumab prophylaxis on HRQoL in hemophilia patients is being investigated further in the ongoing phase 3 trials.
- concizumab (NN7415) / Novo Nordisk
Surgeries and Diagnostic Procedures in Hemophilia Patients on Concizumab Prophylaxis: Results from the Phase 2 Explorer4 and Explorer5 Trials (GWCC - C211-C213, Level 2) - Nov 5, 2021 - Abstract #ASH2021ASH_1709;
P2
A wide range of surgeries, including invasive diagnostic procedures, were conducted while the number of surgery-related bleeds was low and classified as mild or moderate, with 1 exception. Prophylactic treatment with concizumab in patients with hemophilia is currently being investigated further in ongoing phase 3 trials.
- | Hemlibra (emicizumab-kxwh) / Roche, concizumab (NN7415) / Novo Nordisk, fitusiran (ALN-AT3) / Sanofi, Alnylam
Journal: Thrombosis and novel hemophilia therapies: the fine line between clotting and bleeding. (Pubmed Central) - Nov 4, 2021
It is not only the total amount of active thrombin produced that determines the effectiveness of hemostasis but also how thrombin generation is regulated. Therefore, it is currently difficult to predict how these new agents will interact with other perturbations or therapeutic manipulations of the coagulation system.
- | concizumab (NN7415) / Novo Nordisk
Preclinical, Journal: Thrombin generation potential in the presence of concizumab and rFVIIa, aPCC, rFVIII or rFIX: In vitro and ex vivo analyses. (Pubmed Central) - Aug 11, 2021
rFVIIa, aPCC, rFVIII and rFIX enhanced plasma TG potential in the presence of concizumab. Dose levels of concomitant use should be adjusted accordingly to balance potential safety concerns while maintaining the necessary hemostatic effect.
- |||||| Alhemo (concizumab) / Novo Nordisk
New trial: Compassionate Use of Concizumab if You Have Haemophilia (clinicaltrials.gov) - Jun 10, 2021
P, N=0, Available, Sponsor: Novo Nordisk A/S
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] Immunogenicity in the Concizumab Phase 2 Clinical Trials: Clinical Impact of Anti-drug Antibodies (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_2242;
Conclusions : In concizumab phase 2, 25% of patients developed ADAs; the vast majority had low-titer, transient ADAs with no observed clinical effect. Only in one patient with trauma-induced high-titer ADAs, a correlation to clinical impact could be made due to free TFPI restoration; however, the clinical effect remains inconclusive.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] Longer-term Efficacy and Safety of Concizumab Prophylaxis in Hemophilia A and Hemophilia A/B with Inhibitors: Results from the Main and Extension Parts of Concizumab Phase 2 Trials (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_875;
P2
There were no AEs leading to withdrawal, no thromboembolic events, and no deaths during the main and extension parts of either trial. Conclusions : Results from the extension parts of concizumab phase 2 trials were consistent with main-part results, supporting its development as a once-daily, subcutaneous treatment across all hemophilia subtypes.
- concizumab (NN7415) / Novo Nordisk
[VIRTUAL] Safety and Efficacy of Concizumab Prophylaxis Following a Switch from rFVIIa on-demand Treatment: Sub-analysis Results from the Phase 2 Explorer4 Trial in Patients with Hemophilia A or B with Inhibitors (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_864;
P2
There were no safety signals following concizumab switching. Conclusions : Safety and efficacy for explorer4 patients who switched from rFVIIa on-demand to concizumab prophylaxis were consistent with main/extension part trial results, with longer-term efficacy maintained and a favorable safety profile while on concizumab.
- || concizumab (NN7415) / Novo Nordisk, befovacimab (BAY 1093884) / Bayer, marstacimab (PF-06741086) / Pfizer
Review, Journal: Progress in the Development of Anti-tissue Factor Pathway Inhibitors for Haemophilia Management. (Pubmed Central) - May 25, 2021
The anti-TFPIs have several advantages, including their bioavailability when administered subcutaneously, their stable pharmacokinetics and their ability to prevent bleeds in haemophilia A or B patients with and without inhibitors. Whether these advantages can be realized will depend on the outcome of the currently ongoing studies.
- |||| Alhemo (concizumab) / Novo Nordisk
Enrollment closed: explorer7: Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors (clinicaltrials.gov) - May 17, 2021
P3, N=136, Active, not recruiting, Sponsor: Novo Nordisk A/S
Whether these advantages can be realized will depend on the outcome of the currently ongoing studies. Recruiting --> Active, not recruiting
- | concizumab (NN7415) / Novo Nordisk
Journal: Concizumab: a novel anti-TFPI therapeutic for hemophilia. (Pubmed Central) - May 15, 2021
On the basis of phase 2 results, the US Food and Drug Administration granted concizumab Breakthrough Therapy designation for hemophilia B with inhibitor patients, a rare and vulnerable patient subgroup that currently has the highest unmet medical need. In the ongoing concizumab phase 3 trials, an optimized dosing regimen will be administered in patients with hemophilia A or B with and without inhibitors.
- ||||| concizumab (NN7415) / Novo Nordisk
Clinical: New article: TFPI ➡️ #coagulation Anti‐TFPI ab Concizumab is under clinical investigation for subcutaneous prophylaxis of #hemophilia A/B +/- inhibitors. Kjalke et al @novonordisk test thrombin generation potential. 📽️ https://t.co/8z1OYbu6wQ https://t.co/z0QRw20dM9 #openaccess (Twitter) - May 12, 2021