(News Bulletin 247) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (developed in collaboration with Bristol Myers Squibb), have been granted US Food & Drug Administration (FDA) ‘Fast Track’ designation.
As a reminder, this designation aims to expedite the review of data when a drug is likely to provide a substantial improvement in care compared to available therapies and meet an unmet medical need for serious conditions.
The fact that milvexian has received FDA Fast Track designation for all three indications demonstrates the huge unmet need that still exists for the treatment of thrombotic events, such as heart attacks and strokes,” said James F. List. , Head of Global Therapeutic Area at Janssen Research & Development.
“We are now focused on urgently recruiting patients for these trials, which brings us closer to potentially improving outcomes in a wide range of patients with thrombotic diseases,” he added.
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