Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Proteon Therapeutics, a privately held biopharmaceutical company, has received the FDA fast track designation for the development program for PRT-201.
Subscribe to our email newsletter
PRT-201 is being investigated for its ability to improve vascular access in patients currently on or being prepared for hemodialysis. The fast track designation is intended to facilitate development and expedite review for drugs that treat serious diseases and fill unmet medical needs.
PRT-201 is a recombinant human elastase that is being studied for its ability to improve arteriovenous fistula (AVF) surgery outcomes in patients requiring chronic hemodialysis. PRT-201 will also be studied for its ability to improve outcomes after arteriovenous graft (AVG) surgery by prolonging the time that AVGs can be used for chronic hemodialysis without the need for corrective procedures or replacement.
Timothy Noyes, president and CEO of Proteon, said: “This is a very important milestone for us as we prepare to initiate clinical trials with PRT-201 this year. If successful, PRT-201 has the potential to make a very positive difference in the lives of patients who require chronic hemodialysis.”