Relypsa announces FDA approval of supplemental new drug application to enable the usage of Veltassa (patiromer) with or without food

Relypsa

8 May 2018 - Updated label may allow for increased dosing flexibility for patients with hyperkalaemia – a chronic, asymptomatic condition that often coexists with other disorders, including chronic kidney disease, heart failure, diabetes and/or high blood pressure.

Relypsa today announced that the U.S FDA approved a supplemental new drug application for Veltassa (patiromer) for oral suspension in the treatment of hyperkalaemia, or elevated blood potassium levels. 

The label update is effective immediately and based on results from the Phase 4 TOURMALINE study, which showed no statistically significant difference between the groups taking Veltassa with or without food in achieving serum potassium levels within the target range (3.8 to 5.0 mEq/L).

Read Relypsa press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US