FDA grants Cadrenal Therapeutics fast track designation for Tecarfarin
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The FDA granted fast track designation for Tecarfarin, a novel cardiorenal therapy by Cadrenal Therapeutics, to prevent systemic thromboembolism of cardiac origin in patients with end-stage renal disease and atrial fibrillation.
According to the press release, the FDA previously granted orphan drug designation for the vitamin K antagonist oral anticoagulant.
“Patients with ESRD and [atrial fibrillation] AFib have not been well represented in clinical trials evaluating stroke prevention,” Sean Pokorney, MD, MBA, an electrophysiologist, assistant professor of medicine at Duke University and primary investigator for the ACTOR-AF Tecarfarin vs. placebo phase 3 trial, said in the release. “The development of Tecarfarin is an exciting opportunity to collect randomized clinical trial data on stroke prevention in patients with ESRD and AFib, and Tecarfarin provides a unique opportunity to optimize stroke prevention in patients with ESRD and AFib."
According to the Cadrenal Therapeutics website, the phase 3 trial is intended to be a randomized, double-blind, placebo-controlled outcomes study in which researchers compare the effect of Tecarfarin vs. placebo. The cohort consists of 492 patients with ESKD and AFib who are not receiving a chronic oral anticoagulant. This trial is expected to begin in the second half of 2023.
Reference:
Clinical trials. https://www.cadrenal.com/clinical-trials/. Accessed Jan. 23, 2023.
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