In the NDA, OPKO seeks approval of Rayaldee for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
"FDA acceptance of this NDA should be cheered by healthcare professionals who care for CKD patients," commented Dr. Kevin J. Martin, Director of the Division of Nephrology at Saint Louis University School of Medicine.
"If approved, Rayaldee will provide a new therapeutic option for controlling elevated parathyroid hormone levels in this large and undertreated patient population."
OPKO expects written notification of NDA acceptance along with the Prescription Drug User Fee Act (PDUFA) date in the FDA’s 74-Day letter, which the Company expects to receive by mid-August 2015.
The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints, as previously announced.