The FDA has approved orphan drug designation for a new supplemental dialysate solution for patients on peritoneal dialysis.
Zytoprotec, a biopharmaceutical company based in Vienna, Austria, said the special status is for its PD-protec product. The company is preparing a phase 3 clinical trial for the product with 300 patients on peritoneal dialysis in Europe and the United States.
The designation will provide Zytoprotec with several development incentives, including market exclusivity for up to 7 years upon FDA approval, the company said in a press release.
“Attaining orphan designation for PD-protec is an important milestone in our efforts to bring this novel PD fluid closer to market approval,” Bernhard Zinner, managing director of Zytoprotec, said in the release. “We believe that PD-protec has the potential to improve the treatment in an area that has seen little meaningful innovation in decades.”
PD-protec is being developed to prevent complications associated with peritoneal dialysis (PD), particularly the damage caused by PD fluids to abdominal tissue. The product includes a cytoprotective compound to protect peritoneal tissue, thus prolonging the time patients can stay on PD, the company said.
In phase 2 clinical trials, PD-protec demonstrated significant improvement in important biomarkers of peritoneal membrane integrity and peritoneal immune competence, the company said.