Janssen’s Milvexian Gets Fast Track Designation for Three Cardiac Indications

May 26, 2023

Janssen has gained a Fast Track designation for three cardiac indications for milvexian, an investigational oral cardiac drug which offers the potential for anticoagulant treatment with limited bleeding complications.

The drug, being developed in collaboration with Bristol Myers Squibb, has received the designation for treatment of acute coronary syndrome, stroke and atrial fibrillation.

The drug is being studied in nearly 50,000 patients across the three indications in three parallel trials to determine if this Xla inhibitor drug can deliver reduced thrombotic events with no increased risk of bleeding, the company said.

Fast Track Designation is intended to expedite development and review timelines for drugs that provide substantial improvement over available therapies and address unmet medical need for serious or life-threatening conditions. Fast Track Designation encourages close communication between the FDA and sponsor to speed product development, with the aim of getting new therapeutics to patients faster.

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