Crovalimab is under clinical development by F. Hoffmann-La Roche and currently in Phase III for Atypical Hemolytic Uremic Syndrome (Nondiarrhea – Associated Hemolytic Uremic Syndrome). According to GlobalData, Phase III drugs for Atypical Hemolytic Uremic Syndrome (Nondiarrhea – Associated Hemolytic Uremic Syndrome) have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Crovalimab’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.
Crovalimab overview
Crovalimab (Piasky) is an anti-complement C5 recycling antibody. It is formulated as solution for subcutaneous or intravenous route of administration. It is indicated for use in adults and adolescents (≥12 years old) with paroxysmal nocturnal hemoglobinuria who have not received complement inhibitor therapy.
Crovalimab (RO-7112689, RG-6107, SKY-59) is under development for the treatment of vaso-occlusive crisis associated with sickle cell disease, paroxysmal nocturnal hemoglobinuria, lupus nephritis and atypical hemolytic uremic syndrome (aHUS). The drug candidate is administered through the intravenous and subcutaneous route as a solution. The drug candidate is a monoclonal antibody which acts by targeting C5 which is developed based on recycling antibody technology. It is a new molecular entity (NME).
It was also under development for the treatment of Guillain-Barre syndrome.
F. Hoffmann-La Roche overview
F. Hoffmann-La Roche (Roche) is a biotechnology company and a provider of in-vitro diagnostics as well as a supplier of transformative innovative solutions across major disease areas. It provides drugs for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, healthcare professionals, commercial laboratories, researchers and pharmacists. Roche is headquartered in Basel, Switzerland.
For a complete picture of Crovalimab’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.
