Therapy Areas: Devices
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
10 April 2024 -

Cadrenal Therapeutics Inc (Nasdaq: CVKD), a Florida-based biopharmaceutical company, announced on Tuesday that it has received Orphan Drug Designation (ODD) from the United States Food and Drug Administration (FDA) for its tecarfarin, intended for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device (left ventricular assist device (LVAD), right ventricular assist device (RVAD), collectively known as ventricular assist devices (VADs), biventricular assist device, and total artificial heart).

The FDA's ODD program provides incentives to sponsor organisations for the development of innovative treatments for rare diseases that impact fewer than 200,000 people in the United States.

Quang Pham, Cadrenal Therapeutics' founder, chairman and chief executive officer, said: "This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate. We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible."