Japan approves Astellas hyperphosphatemia drug
pharmafile | March 1, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Astellas, Hyperphosphatemia, Japan, Kiklin
Astellas Pharma has received approval from the Ministry of Health, Labour and Welfare in Japan for a supplemental new drug application for Kiklin (bixalomer).
Used as a treatment for hyperphosphatemia in patients with chronic kidney disease (CKD), Kiklin received approval from the Japanese authorities in 2012 for use in patients on dialysis. This new approval will see the drug available to patients with chronic kidney disease, who are not on dialysis.
Hyperphosphatemia occurs in patients with reduced renal function, resulting from decreased excretion into urine via the kidneys which induces consequent accumulation in the body. The risk of renal osteodystrophy characterised by a high tendency of bone pain and bone fracture is known to increase with continuous high blood phosphorous concentration. This is also associated with increased coronary artery calcification and subsequent cardiovascular events. It is therefore considered extremely vital to maintain the serum phosphorus concentration at an appropriate level in CKD patients.
Kiklin is an amine-functional polymer that performs this very function. It decreases the serum phosphorus concentration by binding to phosphate in the gastrointestinal tract, thus inhibiting absorption of phosphate into the human body.
Astellas entered into an agreement in April 2006 that gave it the exclusive rights to develop and commercialise the drug for the treatment of hyperphosphatemia in Japan. The company has indicated that this additional approval for Kiklin will further contribute to the treatment of hyperphosphatemia in patients with CKD.
Sean Murray
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