Pharma Focus Asia

Bristol Myers Squibb and Janssen Pharmaceuticals Collaborate to Receive FDA Fast Track Designation for Milvexian

Thursday, May 25, 2023

Bristol Myers Squibb in collaboration with Janssen Pharmaceuticals announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor, have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA).

The designations cover all three indication-seeking studies within the Phase 3 Librexiadevelopment programme (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients. The Librexia programme is unrivalled as the most comprehensive FXIa clinical development programme to date and will provide extensive data from nearly 50,000 patients.

Despite major advances in cardiovascular and stroke treatment over the past two decades, millions of patients currently remain untreated or undertreated due to the risk of bleeding. If successful, milvexian will open the door to treat an entirely new set of patients, currently overlooked due to bleeding risk.

Milvexian is an investigational, oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia programme, the most comprehensive FXIa clinical development programme to date. Milvexian is an investigational agent and has not been approved for use in any country, for any indication.

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