Ravulizumab LA is under clinical development by Alexion Pharmaceuticals and currently in Phase III for Acute Renal Failure (ARF) (Acute Kidney Injury). According to GlobalData, Phase III drugs for Acute Renal Failure (ARF) (Acute Kidney Injury) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Ravulizumab LA LoA Report. 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.
Ravulizumab LA overview
Ravulizumab (Ultomiris) is a humanized monoclonal antibody. It is formulated as solution and concentrate solution (long acting) for intravenous route of administration. Ultromiris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD), paroxysmal nocturnal hemoglobinuria (PNH), in adults and pediatric patients one month of age and older. Ultomiris is also indicated for the treatment of adults and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Ultomiris is indicated for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmapheresis.
(ALXN-1210, ultomiris) is under development for the treatment of generalized myasthenia gravis (gMG), primary progressive multiple sclerosis, glomerulonephritis-IgA nephropathy (Berger's disease), cardiac surgery-associated acute kidney injury, atypical hemolytic uremic syndrome (aHUS) pediatric, amyotrophic lateral sclerosis, thrombotic microangiopathy-associated haematopoietic stem cell transplant. It is a next-generation Soliris (eculizumab). It is administered intravenously and subcutaneously. The drug candidate is a long-acting anti-C5 antibody act by targeting complement C5 protein. It is developed based on Xencor's Xmab technology that utilizes Xtend Fc domain to enhance the half-life.
It was under development for treatment of dermatomyositis, severe pneumonia and acute lung injury or acute respiratory distress syndrome (ARDS) with COVID-19.
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 brands comprise Kanuma, Koselug, Soliris, StrensIQ and Ultomiris among others. It develops medicines to treat conditions such as atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), hypophosphatasia (HPP), lysosomal acid lipase de?ciency (LAL-D), neurofibromatosis type 1 plexiform neurofibromas (NF1 PN), neuromyelitis optica spectrum disorder (NMOSD) and paroxysmal nocturnal hemoglobinuria (PNH). Alexion’s therapeutic areas include hematology, nephrology, neurology, metabolics, cardiology and others. Alexion collaborates with various research organizations and pharmaceutical companies to develop treatments for rare and severe diseases. 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 Ravulizumab LA’s drug-specific PTSR and LoA scores, buy the report here.
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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.
