Cadrenal Therapeutics receives FDA Orphan Drug Designation for tecarfarin in VAD patients

Cadrenal Therapeutics, Inc.

FDA granted ODD for tecarfarin to prevent thromboembolism/thrombosis in patients with LVADs, RVADs, biventricular assist devices, and total artificial hearts.
ODD provides up to 7 years of U.S. market exclusivity after approval, tax credits for clinical research, and NDA user fee waiver.
This is tecarfarin's second ODD; first was for prevention of systemic thromboembolism in ESKD/AFib patients.
Warfarin achieves target anticoagulation only 56% of the time in VAD patients; DOACs like Eliquis are not indicated for VADs.
Cadrenal CEO states company is dedicated to advancing tecarfarin through clinical development options as swiftly as possible.

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