This designation covers Trinam as a treatment for the prevention of de novo stenosis at vascular surgical anastamoses.
Trinam is an adenovirus-mediated VEGF D gene delivered with a novel biodegradable local delivery device (EG001) and is currently undergoing Phase III development in the US under special protocol assessment, said Ark.
US regulatory review for the product comes under the responsibility of the Center for Biologics Evaluation and Research, the specialist biologics division of the FDA. Trinam has already been given orphan drug status in the US and in Europe. Ark intends to submit a rolling biologic license application for sale and marketing approval in the US in due course.
David Eckland, R&D director at Ark, said: “This is the next important milestone in the regulatory progress of Trinam. The problem of vascular access blocking in kidney dialysis patients has been identified as one of the key medical issues to be resolved in the US and we look forward to working closely with the FDA to expedite the development and review of Trinam.”