Astellas’ sNDA for Kiklin capsules approved in Japan

Astellas Pharma Inc. announced earlier this week that is has obtained approval from the Ministry of Health, Labour and Welfare in Japan for a supplemental new drug application (sNDA) for its product Kiklin capsules 250mg.

Kiklin was originally approved in Japan in June of 2012 for the treatment of patients on dialysis with chronic kidney disease (CKD) who had an indication of hyperphosphatemia. With the approval of the sNDA, Kiklin will be used in the treatment of patients with CKD who have an indication of hyperphosphatemia, but are not currently receiving dialysis treatments.

Patients begin to suffer from hyperphosphatemia when they have reduced renal function due to decreased phosphate excretion into urine through the kidney. This results in the buildup of phosphate in the body. If phosphorous levels continue to accumulate to a high level in the blood, patients will have an increase chance of developing renal osteodystrophy, which raises the chances of bone pain and fractures.

High phosphorous levels in the blood can also lead to coronary artery calcification and cardiovascular issues. This makes it of the utmost importance to keep phosphorous levels in the blood at a normal level in patients with CKD.