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Relypsa’s Potassium-Lowering Drug Clears FDA, But Dosing Warning Could Impact Use

 
• By Brenda Sandburg

Boxed warning says other oral drugs should be taken at least 6 hours before or after; Veltassa to launch in January with support from Sanofi’s sales force.

Relypsa Inc. won FDA approval of Veltassa (patiromer) with a broad label for treatment of hyperkalemia. However, the label includes a box warning about the potential for the drug to bind to other oral medications and the need for a six-hour separation between their administration and Veltassa, which has the potential to make use more difficult.

During an Oct. 22 conference call, investors asked questions almost exclusively about the warning and Relypsa’s ongoing drug-drug interaction Phase I studies, which are evaluating Veltassa’s potential to bind with 12 drugs that showed moderate to strong binding in in vitro testing (see box for list of drugs)

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