The US Food and Drug Administration (FDA) has approved a label update proposed by Relypsa Inc, part of Swiss-based Vifor Pharma (VTX: VIFN), for Veltassa (patiromer), the US biopharmaceutical company revealed on Tuesday.
Effective immediately, the change enables the use of Veltassa with or without food.
According to the company, this may allow for increased dosing flexibility for patients with hyperkalemia (elevated blood potassium) -- a chronic, asymptomatic condition that often coexists with other disorders, including chronic kidney disease, heart failure, diabetes and/or high blood pressure.
Approval of Relypsa's supplemental New Drug Application (sNDA) was 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).
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