BMS/Janssen Will Begin Phase III For Factor XIa Inhibitor Milvexian By Year-End

Phase II Showed Potential Beyond Prior Anticoagulants

Bristol and Janssen reported Phase II data at the ESC Congress in secondary stroke prevention, an indication not covered by Factor Xa inhibitors. BMS unveiled a three-indication Phase III program.

stethoscope twisted in heart shape lying on cardiogram chart closeup
BMS unveiled three Phase III indications: secondary stroke prevention, acute coronary syndrome and atrial fibrillation • Source: Shutterstock

With data in hand from two Phase II clinical trials of milvexian, Bristol Myers Squibb Company and the Janssen Pharmaceutical Cos. of Johnson & Johnson now plan to kick off a Phase III program later this year to show definitively whether the Factor XIa inhibitor can be developed beyond the approved indications for the class’s predecessors – Factor Xa inhibitors, such as the BMS/Pfizer Inc. blockbuster anticoagulant Eliquis (apixaban).

Bristol and Janssen presented positive Phase II results on 28 August at the European Society of Cardiology (ESC) Congress in Barcelona from the AXIOMATIC-SSP trial testing milvexian in secondary stroke prevention (SSP)

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