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

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.