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Relypsa Expects Approval Decision on Wednesday Potassium-Lowering Drug


Relypsa (RLYP) is aiming to secure U.S. approval Wednesday for its first drug -- a new treatment to help patients with dangerously high levels of potassium in their blood.

A positive nod from the U.S. Food and Drug Administration will prompt Redwood City, Calif-based Relypsa to finalize the hiring of a salesforce and start selling the drug within the next two months, said company spokesperson Charlotte Arnold.

Getting an early jump on a commercial launch could be enormously important for Relypsa because a competing treatment from ZS Pharma (ZSPH) is also under FDA review with a decision expected in the middle of next year.

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The Relypsa drug patiromer targets hyperkalemia, a condition in which potassium levels in the blood become abnormally high, usually due to poorly functioning kidneys or as a side effect from medicines taken by people to manage heart failure and chronic kidney disease. Elevated potassium can cause abnormal heart rhythm and in worse cases, sudden death.

Patiromer is a powder suspended in a small amount of water. When swallowed, the drug binds to excess potassium in the gut, and removes it. Across multiple clinical trials, Relypsa showed patiromer reduces potassium levels back to a normal range and maintains that range...