Astellas Receives Approval for a Supplemental New Drug Application for Kiklin Capsules

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The FINANCIAL — Astellas Pharma Inc. on February 29 announced that it received an approval for a supplemental new drug application for “Kiklin Capsules 250mg from the Ministry of Health, Labour and Welfare in Japan.

In June 2012, Astellas launched Kiklin, approved for the indication of hyperphosphatemia in patients on dialysis with chronic kidney disease, in Japan. With this approval, Kiklin is indicated for the treatment of hyperphosphatemia, allowing the use of this product for patients suffering from CKD who are not receiving dialysis, according to Astellas Pharma.

Hyperphosphatemia occurs in patients with reduced renal function, resulting from decreased phosphate excretion into urine via kidney which induces consequent accumulation in the body. With continuous high blood phosphorus concentration, the risk of renal osteodystrophy characterized by a high tendency of bone pain and bone fracture is known to increase. Additionally, high blood phosphorus concentration is associated with increased coronary artery calcification and subsequent cardiovascular events. Therefore, it is considered extremely important to maintain the serum phosphorus concentration at an appropriate level in CKD patients.

Kiklin is an amine-functional polymer which decreases the serum phosphorus concentration by binding to phosphate in the gastrointestinal tract, thus inhibiting absorption of phosphate into the human body.

In April 2006, Astellas and Ilypsa, Inc., now a wholly-owned subsidiary of Amgen Inc., entered into a license agreement that grants Astellas exclusive rights to develop and commercialize Kiklin for the treatment of hyperphosphatemia in Japan. Since then, Astellas has conducted development activities for Kiklin in Japan. Astellas and Sanwa Kagaku Kenkyusho Co., Ltd. co-promote Kiklin while Astellas is solely responsible for its distribution.

Astellas expects that the additional indication for Kiklin will further contribute to the treatment of hyperphosphatemia in patients with CKD.

 

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