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Confidence In Factor XIa Inhibition Wavers After Bristol/Janssen And Bayer Data

High Expectations For Next Big Oral Anticoagulant Drug Class

 
• By Mandy Jackson

BMS/Janssen’s milvexian and Bayer’s asundexian prevented strokes without major increases in severe bleeding and no fatal bleeds but Phase III outcomes are uncertain based on mixed Phase II data.

Red question mark on a background of black question marks
Phase II trials left several unanswered questions for milvexian and asundexian • Source: Shutterstock

Factor XIa inhibition is a new oral anticoagulant drug class that carries the promise of protecting patients from strokes without the higher risk of bleeding associated with predecessor drugs, the blockbuster Factor Xa inhibitors. However, new Phase II data for the two most advanced oral Factor XIa inhibitors – milvexian from Bristol Myers Squibb Company/Janssen Pharmaceutical Cos. and Bayer AG’s asundexian – raise new questions about the drugs’ future.

BMS and Janssen, a Johnson & Johnson company, reported results from the Phase II AXIOMATIC-SSP clinical trial evaluating multiple doses of milvexian in combination with dual antiplatelet therapy (DAPT) in secondary stroke prevention (SSP)

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