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Eliquis’ European Label Supports Superiority Claims

This article was originally published in The Pink Sheet Daily

Executive Summary

Bristol and Pfizer expect to launch novel anticoagulant Eliquis within weeks in Germany and the U.K. following approval in Europe on Nov. 20. Eliquis looks well-positioned to compete in Europe with a label reflecting superiority on safety, efficacy for stroke prevention and mortality.

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Germany’s IQWiG Approves Eliquis For AF, But Restricts Its Indication

Germany’s HTA IQWiG has approved Bristol/Pfizer’s Eliquis (apixaban) for atrial fibrillation but restricted the oral anticoagulant’s indication, leaving a potential gap for its rivals to fill.

Eliquis Label Looks Great, But May Leave Door Open For Pradaxa To Compete On Efficacy

Bristol/Pfizer’s Eliquis secures an attractive FDA label for atrial fibrillation on three key fronts: superior stroke prevention, reduced major bleeding and reduced all-cause mortality. With its superiority in preventing hemorrhagic strokes, Eliquis has the clear lead in terms of safety. But Boehringer’s competing Pradaxa remains the only new oral anticoagulant with proven superiority for preventing purely ischemic strokes, which is the main goal of atrial fibrillation treatment.

AMPLIFY-EXT Puts Eliquis In Position For A New VTE Indication

The long-term prevention trial had a unique design in that it tested two different doses of Bristol/Pfizer’s anticoagulant apixaban. Both doses demonstrated an 80% reduction in events compared to placebo, but without an increase in major bleeding – reinforcing Eliquis’ strong safety profile.

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