Cadrenal Granted FDA Fast Track Designation for Tecarfarin for Prevention of Blood Clots

The U.S. Food and Drug Administration granted a Fast Track designation to Cadrenal Therapeutics’ tecarfarin for the prevention of blood clots in patients with end-stage renal disease and atrial fibrillation.

Photo: Quang Pham, CEO of Cadrenal

“The Fast Track designation for tecarfarin is an important milestone in the development of this therapy and highlights the importance of finding an effective treatment for the prevention of blood clots of cardiac origin in patients with ESRD and AFib,” said Quang Pham, CEO of Cadrenal.

Tecarfarin is a vitamin K antagonist oral anticoagulant designed to target a different pathway than the most commonly prescribed drugs used in the treatment of thrombosis and AFib. Tecarfarin has been evaluated in eleven human clinical trials and in more than 1,000 individuals. In phase 1, phase 2 and phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (CKD).

“Patients with ESRD and AFib have not been well represented in clinical trials evaluating stroke prevention,” said Sean Pokorney, an electrophysiologist, assistant professor of medicine at Duke University, and primary investigator for the ACTOR-AF Tecarfarin versus placebo phase 3 Trial. “The development of tecarfarin is an 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.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

A drug that receives Fast Track designation is eligible for some or all of the following: more frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval; more frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers; eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

The FDA had previously granted an Orphan Drug Designation for tecarfarin.

Author: Rare Daily Staff