Calico Life Sciences announced on Thursday that the U.S. Food and Drug Administration (FDA) has issued Fast Track Designation for ABBV-CLS-628, a kidney disease therapy developed by the company in partnership with AbbVie (NYSE:ABBV).
The treatment targeting autosomal dominant polycystic kidney disease is currently undergoing a Phase 2 trial for the indication involving nearly 95 trial sites globally, the San Francisco, California-based biotech said.
Characterized by the formation of fluid-filled cysts in the kidneys, ADPKD is the most common genetically developed kidney disease in the world. More than 50% of patients with ADPKD can develop kidney failure before they reach 60 years, requiring dialysis or a transplant as the only available treatment options.
The FDA fast-track designation allows a faster timeline for the development and review of drugs for serious conditions with unmet medical needs. Subject to certain conditions, companies with fast-track designations can secure the FDA’s accelerated approval and priority review to bring their products to market sooner.