Ravulizumab LA is under clinical development by Alexion Pharmaceuticals and currently in Phase III for IgA Nephropathy (Berger’s Disease). According to GlobalData, Phase III drugs for IgA Nephropathy (Berger’s Disease) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ravulizumab LA’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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Data Insights Likelihood of Approval and Phase Transition Success Rate Model - Ravulizumab LA in IgA Nephropathy (Berger's Disease)

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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 a solution and concentrate solution (long-acting) for the intravenous route of administration. Ultromiris is indicated for neuromyelitis optica spectrum disorder (NMOSD), and 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 generalized 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) in pediatrics, neuromyelitis optica spectrum disorder, cardiac surgery-associated acute kidney injury, chronic kidney disease, thrombotic microangiopathy-associated hematopoietic stem cell transplant, glomerulonephritis-IgA nephropathy (Berger's disease) and lupus nephritis. It is a next-generation Soliris (eculizumab). It is administered through intravenous and subcutaneous routes. The drug candidate is a long-acting anti-C5 antibody that acts by targeting the complement C5 protein. It is being developed based on Xencor's Xmab technology that utilizes the Xtend Fc domain to enhance the half-life.
It was under development for treatment of dermatomyositis, severe pneumonia, acute lung injury or acute respiratory distress syndrome (ARDS) with COVID-19, primary progressive multiple sclerosis, atypical hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH) in EU and myasthenia gravis in adults. It was also under development for ALS.

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 Ravulizumab LA’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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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.