Rayaldee (vitamin D prohormone)is filed at FDA for secondary hyperparathyroidism in patients with CKD- OPKO Health.
OPKO Health, Inc.has announced that it has submitted a New Drug Application (NDA) for oral Rayaldee (vitamin D prohormone) to the FDA. The NDA requests marketing approval for 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.
The Rayaldee application is supported by positive 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.
Comment: Rayaldee, an oral small molecule drug is at least a few months ahead of the Amgen's intravenous drug candidate AMG 416 (KAI-4169, velcalcetide), which is expected to make up for lost market share when Amgen loses patent protection for its blockbuster drug Sensipar/Mimpara in 2015(EU) and 2018(US).
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