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AstraZeneca (AZN.US) initiates the 3rd phase clinical trial in China, aiming to evaluate the efficacy of Revasculin.

AInvestFriday, Aug 2, 2024 2:30 am ET
1min read

China Pharmaceutical Clinical Trial Register and Information Public Platform recently announced that AstraZeneca (AZN.US) and its subsidiary Alexion had launched a Phase 3 clinical trial in China to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of ravulizumab in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who are receiving a C5 complement inhibitor as initial therapy.

Ravulizumab is a highly effective C5 complement inhibitor developed by Alexion. In this Phase 3 clinical trial, patients will receive an induction dose on Day 1, followed by a maintenance dose every 15 days thereafter. The study includes a 26-week primary treatment period and a 32-week extension period, with a total of 18 patients planned to be recruited in China.

Source: China Pharmaceutical Clinical Trial Register and Information Public Platform

Ravulizumab is a highly effective C5 complement inhibitor with immediate, complete and sustained complement inhibition. Its unique design provides a longer half-life than first-generation C5 complement inhibitors. It was first approved by the US FDA in 2018 for the treatment of PNH, allowing patients to effectively control hemolysis with only one injection every 8 weeks. Since then, the drug has been approved by the FDA for the treatment of a variety of autoimmune diseases, including atypical hemolytic uremic syndrome, severe myasthenia gravis, and optic neuritis.

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