Vascugel granted fast-track designation by FDA

CAMBRIDGE, Mass. — The Food and Drug Administration has given expedited review to a drug for preventing hemodialysis failure in patients with end-stage kidney disease.

The FDA granted fast-track review status to the cell-based therapy Vascugel, made by Pervasis Therapeutics. The FDA grants the status to accelerate review of treatments for serious and life-threatening conditions, particularly those that address serious, unmet medical conditions.

Hemodialysis is used to filter the blood in patients with end-stage kidney disease, but patients can experience complications that cause clotting of the vascular access points used in hemodialysis that renders them unusuable, also known as hemodialysis access failure. Vascugel is designed to prevent this clotting.