Cadrenal Therapeutics (NASDAQ: CVKD) announced plans to submit a Rare Pediatric Disease Designation (RPDD) request to the FDA for tecarfarin as a treatment for pediatric patients with Kawasaki disease (KD) who develop coronary artery aneurysms (CAAs) and require chronic oral anticoagulation.
According to Cadrenal, if the RPDD is granted and tecarfarin is approved for KD, the company would be eligible to receive a Priority Review Voucher valued at approximately $200 million.
In a statement, Quang X. Pham, CEO of Cadrenal, commented, “Children with large or giant aneurysms due to KD represent an important underserved orphan population. The current standard of care – warfarin – is notoriously unstable in children because of dietary variations, concurrent medications, and genetic differences in liver metabolism. Tecarfarin is metabolized in a completely different way than warfarin, and is being developed to offer a highly stable, predictable alternative. We believe tecarfarin can potentially improve time in therapeutic range for these children, thereby lowering their risk for both catastrophic blood clots and dangerous bleeding events.”
