AstraZeneca moves early for full approval with anticoagulant reversal drug Andexxa after positive PhIV data
AstraZeneca is ready to take its anticoagulant reversal agent Andexxa into full approval from accelerated approval with the FDA, the company announced Monday, based on data from a post-marketing Phase IV trial.
The company is stopping the trial early based on a recommendation from an independent Data and Safety Monitoring Board after an interim efficacy assessment of 450 randomized patients showed Andexxa’s reversal benefits earlier in the study enrollment than originally planned.
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