Trade Resources Industry Views Astellas Pharma Received Japanese Marketing Approval for Kiklin Capsules

Astellas Pharma Received Japanese Marketing Approval for Kiklin Capsules

Astellas Pharma has received Japanese marketing approval for Kiklin capsules to treat hyperphosphatemia in patients on dialysis with chronic kidney disease.

Kiklin capsules, amine-functional polymers, bind to phosphate in the gastrointestinal tract and decrease the serum phosphorus concentration, there by inhibiting absorption of phosphate into the human body.

Phase III studies demonstrated Kiklin capsules' clinical efficacy in decreasing serum phosphorus concentration, as well as a preferable long-term safety profile.

Astellas Pharma and Sanwa Kagaku Kenkyusho had entered into a strategic alliance under which, both the companies will co-promote the drug while Astellas will oversee distribution.

Hyperphosphatemia occurs in patients receiving dialysis whose renal function is reduced, because phosphorus is not sufficiently excreted into urine via the kidneys and accumulates in the body.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/astellas-wins-japanese-marketing-approval-for-kiklin-capsules-030412
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Astellas Wins Japanese Marketing Approval for Kiklin Capsules