RTA 402 is currently being studied in a Phase I/II trial in patients with pancreatic cancer, and is also in Phase II development for chronic kidney disease.
Warren Huff, CEO of Reata, said: “Pancreatic cancer is a devastating disease with few effective therapies. We are encouraged by the initial results with RTA 402 in pancreatic cancer, and are pleased that the FDA has recognized this potential by granting orphan drug status.”
Orphan drug designation provides an important economic incentive for the development of new products in the cancer field. US orphan drug designation provides for seven years of market exclusivity, reduction in regulatory fees, and additional regulatory support for R&D initiatives.