image credit: Freepik

BMS and Janssen’s antithrombotic granted FDA fast track designation

May 26, 2023


The designations for the investigational oral factor XIa inhibitor cover all three indication-seeking studies within the phase 3 Librexia development programme: ischaemic stroke, acute coronary syndrome and atrial fibrillation.

According to the companies, the programme aims to evaluate whether milvexian can enhance the benefit-risk profile associated with treating patients with these three conditions by delivering reduced thrombotic events with no increased risk of bleeding.

Read More on PMLiVE