The orphan designation will provide Zytoprotec with several development incentives including market exclusivity for up to seven years upon FDA approval.
- Dialysis solution to improve outcomes of peritoneal dialysis
- Phase III clinical trial under preparation in Europe and the United States
Vienna, Austria, December 14, 2017 / B3C newswire / -- Zytoprotec, a biopharmaceutical company developing innovative dialysis fluids, announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designation to PD-protec®, the Company’s peritoneal dialysis fluid for the treatment of patients with end-stage renal disease (kidney failure).
Zytoprotec is currently preparing a pivotal Phase III clinical trial with PD-protec® in 300 patients suffering from end-stage renal disease in Europe and the United States.
Orphan drug designation is a special status granted by the FDA to treatments for rare diseases that affect fewer than 200,000 people in the United States. The orphan designation will provide Zytoprotec with several development incentives including market exclusivity for up to seven years upon FDA approval.
„Attaining orphan designation for PD-protec® is an important milestone in our efforts to bring this novel PD fluid closer to market approval,“ said Bernhard Zinner, Managing Director of Zytoprotec. „Chronic kidney failure is a life-threatening condition that puts an immense burden on patients and also on the health-care system. We believe that PD-protec® has the potential to improve the treatment in an area that has seen little meaningful innovation in decades.“
„In a recent Phase II clinical study PD-protec® successfully met both endpoints and we are eager to corroborate the benefits of this novel dialysis fluid in a pivotal Phase III trial in Europe and in the United States,“ Bernd Seibel, Managing Director of Zytoprotec, added.
