BioCentury
ARTICLE | Clinical News

Kiklin bixalomer regulatory update

October 12, 2015 7:00 AM UTC

Astellas submitted an sNDA to Japan for a granule formulation of Kiklin bixalomer to treat hyperphosphatemia in patients on dialysis with chronic kidney disease (CKD). In 2012, Astellas launched a capsule formulation of the metal-free, non-absorbed polymeric phosphate-binding agent for the indication in the country. Last March, Astellas submitted an sNDA for Kiklin to treat CKD patients not on dialysis with hyperphosphatemia. ...