Bristol-Myers: fast track status for milvexian
(CercleFinance.com) - Bristol Myers and Johnson & Johnson's Janssen Pharmaceutical Companies today announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (developed in collaboration with Bristol Myers Squibb), have been granted Fast Track designation by the US FDA.
This designation is intended to expedite the review of data when a drug is likely to provide a substantial improvement in care over available therapies and address an unmet medical need for serious conditions.
The fact that milvexian has received Fast Track designation from the FDA for all three indications demonstrates the enormous unmet need that still exists for the treatment of thrombotic events, such as heart attacks and strokes, Janssen R&D said.
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This designation is intended to expedite the review of data when a drug is likely to provide a substantial improvement in care over available therapies and address an unmet medical need for serious conditions.
The fact that milvexian has received Fast Track designation from the FDA for all three indications demonstrates the enormous unmet need that still exists for the treatment of thrombotic events, such as heart attacks and strokes, Janssen R&D said.
Copyright (c) 2023 CercleFinance.com. All rights reserved.