h date will be announced as soon as a decision is made.
Outline of approval
Product Name: Riona® Tablets 250mg
Generic Name: Ferric Citrate Hydrate
Indications: Improvement of hyperphophatemia in patients with chronic kidney disease
Both dialysis and non-dialysis dependent CKD patients are included.
Dosage and Administration:
The usual adult dosage for oral use begins at 500 mg of ferric citrate three times daily immediately after meals. Thereafter, the dosage
should be adjusted based on the degree of symptoms and serum phosphorus concentration. The maximum daily dosage is 6,000 mg.
About ferric citrate hydrate
JT and Torii hold the exclusive rights to develop and commercialize ferric citrate hydrate in Japan, which were licensed in September 2007 from Keryx
Biopharmaceuticals, Inc. Since then, JT and Torii have jointly conducted the development of the drug, and JT submitted a New Drug Application (NDA) to the
Japanese Ministry of Health, Labour and Welfare in January 2013.
In the United States, Keryx filed its NDA with the U.S. Food and Drug Administration and has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014.
About hyperphosphatemia
Patients with CKD often suffer from hyperphosphatemia, as a result of lower phosphorous excretion from the kidney. Persisting hyperphosphatemia leads to
calcareous deposition in various organs and periarticular tissues. In particular, a calcified blood vessel wall causes arterial sclerosis and increases the risk of cardiac infarct and angina. Furthermore, bone lesions can be caused by secondary hyperparathyroidism associated with the increase in secretion of parathyroid hormone, negatively affecting activities of daily living and quality of life.
Therefore, it is important for hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD, to maintain the target level of serum phosphorus.
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