The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to vonapanitase (Proteon Therapeutics) for increasing arteriovenous fistula secondary patency and improving use for hemodialysis.

Patients on hemodialysis require a high-flow vascular access to connect the patient’s bloodstream to the dialysis machine. The preferred form is a radiocephalic arteriovenous fistula which connects a vein to an artery in the patient’s forearm, resulting in a substantial increase in blood flow and vein dilation. Vonapanitase, an investigational drug, is designed to improve fistula secondary patency (eg, survival of the fistula without abandonment) and use for hemodialysis. 

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The Breakthrough Therapy designation was based on data from the PATENCY-1 study, the first Phase 3 trial evaluating vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula. The primary endpoint of improving primary patency was not met, however, data showed that vonapanitase demonstrated clinically meaningful improvements in secondary patency and use for hemodialysis.

A second Phase 3 trial for vonapanitase in hemodialysis patients, PATENCY-2, is currently ongoing and is expected to complete enrollment in the first quarter of 2018. The co-primary endpoints are secondary patency and fistula use for hemodialysis. Proteon expects to report findings from PATENCY-2 and submit a BLA to the FDA in 2019.

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