Eculizumab is under clinical development by Alexion Pharmaceuticals and currently in Phase III for Coronavirus Disease 2019 (COVID-19) Pneumonia. According to GlobalData, Phase III drugs for Coronavirus Disease 2019 (COVID-19) Pneumonia have an 8% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Eculizumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Eculizumab overview
Eculizumab (Soliris) is a humanized monoclonal antibody directed against terminal complement protein C5. Soliris is formulated as injectable concentrated solution and injectable solution for intravenous route of administration. Soliris is indicated for the treatment of paroxysmal nocturnal hemoglobinuria in patients without a history of transfusion, atypical hemolytic uremic syndrome, for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy and for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Soliris (eculizumab) also indicated to include the treatment of refractory generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Eculizumab is also under development for the treatment of liver transplant rejection, paroxysmal nocturnal hemoglobinuria, Guillain-Barre Syndrome and for the treatment of brain injury in patients with aneurysmal subarachnoid hemorrhage and coronavirus disease 2019 (COVID-19) pneumonia, coronavirus disease 2019 (COVID-19) associated acute lung injury, coronavirus disease 2019 (COVID-19) associated acute respiratory distress syndrome.
It was also under development for the prevention of antibody mediated rejection (AMR) in presensitized kidney transplant patients, treatment of membranoproliferative glomerulonephritis (MPGN type II, dense deposit disease), C3 glomerulonephritis (C3GN), allergic asthma, relapsing neuromyelitis optica spectrum disorder (NMOSD), psoriasis, anti-neutrophil cytoplasmic antibody-associated vasculitis, dermatomyositis, Shiga-toxin producing Escherichia Coli hemolytic-uremic syndrome (STEC-HUS), rheumatoid arthritis and dry age-related macular degeneration,cold agglutinin disease and for the prevention of delayed kidney transplant graft function (DGF) after solid organ transplantation.
Alexion Pharmaceuticals overview
Alexion Pharmaceuticals (Alexion), a subsidiary of AstraZeneca Plc, discovers, develops and markets therapies for severe and life-threatening diseases. The company’s pipeline products include ALXN2030, ALXN1920, ULTOMIRIS, Vemircopan for nephrology; ALXN2220, Anselamimab, Acoramidis treats cardiology; ALXN1910 which targets bone metabolism; Gefurulimab for neurology; Danicopan targets ophthalmology. The company’s medicinal brands comprise Kanuma, Koselug, Soliris, StrensIQ, Ultomiris and Voydeya. Alexion collaborates with various research organizations and pharmaceutical companies. The company operates in Europe and the Middle East, North America, Latin America and Asia Pacific. Alexion is headquartered in Boston, Massachusetts, the US.
For a complete picture of Eculizumab’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
