Soliris (eculizumab) / AstraZeneca 
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 85 Diseases   26 Trials   26 Trials   4615 News 


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  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Toward complement inhibition 2.0: Next generation anti-complement agents for paroxysmal nocturnal hemoglobinuria. (Pubmed Central) -  May 7, 2019   
    Therapeutic complement inhibition by eculizumab has revolutionized the treatment of paroxysmal nocturnal hemoglobinuria (PNH) with a major impact on its natural history...Upstream complement inhibitors include the anti-C3 small peptide compstatin (and its derivatives), and small inhibitors of complement factor D or complement factor B. This class of compound anticipates a possible efficacy in prevention of C3-mediated extravascular hemolysis, in addition to inhibition of intravascular hemolysis, possibly leading to improved hematological responses. The availability of all these compounds will result soon in a substantial improvement of PNH management.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Clinical, Journal:  Pediatric Malignant Atrophic Papulosis. (Pubmed Central) -  May 7, 2019   
    Nonetheless, because the C5b-9 complex is detected in MAP, some researchers have suggested combined treatment with eculizumab (a humanized monoclonal antibody against C5) and treprostinil (a prostacyclin analog). Here, we report on a girl with systemic MAP who had severe central nervous system involvement and responded to eculizumab.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Clinical, Journal:  Recurrent case of pregnancy-induced atypical haemolytic uremic syndrome (P-aHUS). (Pubmed Central) -  May 5, 2019   
    The patient normalised her haematological parameters within 1 week but sustained dialysis-requiring renal failure for a total of 6 weeks. This case highlights the advances as well as the ongoing uncertainties, especially with respect to the use of eculizumab, in this rare but morbid disease.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Neurology (Pubmed Central) -  Apr 30, 2019   
    A form of gene therapy, patisiran, has shown positive results in transthyretin familial amyloidosis...The criteria for Lewy body dementia have been revised. Generic use of lamotrigine does not result in recrudescence of epileptic seizures or adverse effects.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Multifocal motor neuropathy. (Pubmed Central) -  Apr 28, 2019   
    Monitoring of disease and response to treatment may improve using disease-specific evaluation scales such as MMN-Rasch-built overall disability scale. Further research into the pathophysiology of MMN is necessary to direct future treatment strategies.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Corticosteroids and Anti-Complement Therapy in Retinal Diseases. (Pubmed Central) -  Apr 26, 2019   
    Complement factor inhibitors, such as POT-4, lampalizumab, and eculizumab, have been tested in clinical trials for dry AMD with promising results. However, results of phase 3 trials are awaited.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Eculizumab in refractory myasthenic crisis. (Pubmed Central) -  Apr 26, 2019   
    However, results of phase 3 trials are awaited. No abstract available
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Novel Approaches to Block Complement. (Pubmed Central) -  Apr 24, 2019   
    Moreover, modified apheresis techniques for preferential removal of macromolecules, including C1q, may allow for efficient complement depletion, in addition to antibody removal. The availability of effective strategies to interfere with the CP, as well as innovative approaches targeting other pathways, some of them already being tested in clinical trials, will help us figure out how complement contributes to acute and chronic graft injury, and hopefully provide us with new ways to more efficiently counteract rejection.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Clinical, Review, Journal:  C3-mediated extravascular hemolysis in PNH on eculizumab: Mechanism and clinical implications. (Pubmed Central) -  Apr 21, 2019   
    The treatment of the few PNH patients in which this de novo extravascular hemolysis become clinically relevant is still unsatisfactory. Nevertheless, the investigations of the mechanisms responsible of the extravascular hemolysis on eculizumab have resulted in the development of novel strategies for complement blockade that could overcome this condition.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Review, Journal:  Anticomplement Treatment in Atypical and Typical Hemolytic Uremic Syndrome. (Pubmed Central) -  Apr 21, 2019   
    The efficacy of eculizumab in Shiga toxin producing Escherichia coli-associated HUS is not to date established and the results of ongoing prospective studies are eagerly awaited. Nevertheless, the emergence of anticomplement therapies (eculizumab and other drugs in development) has transformed our approach of HUS.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Review, Journal:  Expanding Complement Therapeutics for the Treatment of Paroxysmal Nocturnal Hemoglobinuria. (Pubmed Central) -  Apr 21, 2019   
    ...The clinical application of eculizumab, a humanized anti-C5 antibody that blocks terminal pathway activation, has led to drastic improvement of therapeutic outcomes but has also unveiled hitherto elusive pathogenic mechanisms that are now known to contribute to the clinical burden of a significant proportion of patients with PNH...Here, we review the current state of complement therapeutics with a focus on the clinical development of C3-targeted and alternative pathway-directed drug candidates for the treatment of PNH. We also discuss the relative advantages and benefits offered by each complement-targeting approach, including translational considerations that might leverage a more comprehensive clinical intervention for PNH.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Trial completion date, Trial primary completion date:  Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (clinicaltrials.gov) -  Apr 20, 2019   
    P3,  N=117, Active, not recruiting, 
    We also discuss the relative advantages and benefits offered by each complement-targeting approach, including translational considerations that might leverage a more comprehensive clinical intervention for PNH. Trial completion date: Jan 2019 --> Jan 2020 | Trial primary completion date: Jan 2019 --> Jan 2020
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Rituxan (rituximab) / Roche, Biogen
    Journal:  Advances in autoimmune myasthenia gravis management. (Pubmed Central) -  Apr 14, 2019   
    As a rare disease, clinical trials are challenged in patient recruitment. The great interest in development of treatments specific for MG is welcome, but decisions will need to be made to focus on those that offer significant benefits to patients.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Biomarker, Clinical, Journal:  Developments in anti-complement therapy; from disease to clinical trial. (Pubmed Central) -  Apr 9, 2019   
    In this review we discuss the indications which are in the drug development 'spotlight' and review the relevant indication validation criteria. We present current progress in clinical trials, highlighting successes and difficulties, and look forward to approval of a wide selection of drugs for use in man which give clinicians choice in mechanistic target, modality and route of delivery.
  • ||||||||||  SB12 (eculizumab biosimilar) / AffaMed Therap, Samsung
    Trial completion:  Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects (clinicaltrials.gov) -  Apr 8, 2019   
    P1,  N=240, Completed, 
    We present current progress in clinical trials, highlighting successes and difficulties, and look forward to approval of a wide selection of drugs for use in man which give clinicians choice in mechanistic target, modality and route of delivery. Recruiting --> Completed
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Journal:  Eculizumab: A Review in Generalized Myasthenia Gravis. (Pubmed Central) -  Apr 7, 2019   
    Eculizumab was generally well tolerated in these studies, with a tolerability profile similar to that reported previously in other indications. Although several questions remain, such as duration of treatment, cost effectiveness and long-term efficacy and tolerability, current evidence indicates that eculizumab is a valuable emerging therapy for patients with refractory gMG.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Clinical, Journal:  Fatal Nongroupable Neisseria meningitidis Disease in Vaccinated Patient Receiving Eculizumab. (Pubmed Central) -  Apr 5, 2019   
    Patients receiving eculizumab have an increased risk for meningococcal disease, but most reported cases are attributable to encapsulated meningococcal strains. We describe a case in which a nongroupable meningococcal strain, which rarely causes disease in healthy persons, caused fatal disease in an eculizumab recipient despite meningococcal vaccination.
  • ||||||||||  Soliris (eculizumab) / AstraZeneca
    Enrollment open:  A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov) -  Apr 1, 2019   
    P3,  N=12, Recruiting, 
    Transplantation of TCRalfa/beta and CD19 depleted hematopoietic cells from matched unrelated donor after immunoablative conditioning and supported with short course of eculizumab is perfectly safe and efficient technology leading to cure in young patients with PNH. Not yet recruiting --> Recruiting
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Rituxan (rituximab) / Roche, Biogen
    Journal:  Severe refractory idiopathic warm autoimmune haemolytic anaemia responsive to complement inhibition with eculizumab. (Pubmed Central) -  Mar 30, 2019   
    Off-label use of the terminal complement pathway inhibitor, eculizumab, led to rapid amelioration of the haemolysis, presumably by the inhibition of an intravascular component, and allowed time for slower acting immunosuppressive agent to take effect. This novel approach warrants further evaluation, given the poor prognosis of multirefractory wAIHA.
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Clinical, Journal:  Long-term Use of Eculizumab in Kidney Transplant Recipients. (Pubmed Central) -  Mar 24, 2019   
    Prolongation of pregnancy and the use of eculizumab, even for only a few weeks, may protect not only maternal renal function, but also alleviate acute and long-term renal consequences of prematurity in offspring. No abstract available
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma
    Clinical, Journal:  Eculizumab Use for Kidney Transplantation in Patients With a Diagnosis of Atypical Hemolytic Uremic Syndrome. (Pubmed Central) -  Mar 24, 2019   
    Outcomes for transplant patients with aHUS treated with eculizumab were improved compared with previous reports of patients with aHUS not treated with eculizumab. Our findings suggest delayed aHUS diagnosis and therefore treatment is associated with an increased risk of dialysis posttransplantation and reduced allograft function.