Shots:

• The MHLW’s approval is based on stand-alone studies in Japan and global clinical programs and is supported by DIALIZE study that demonstrated the efficacy on Lokelma in treating hyperkalemia patients with ESRD on hemodialysis
• The global clinical program result: @12mos. the median time to achieve normal potassium levels in the blood (22hrs.) with 98% achieving normal levels within 48hrs. The therapy demonstrated a reduction in blood potassium level in 1hr. with 1 dose and a sustained treatment effect for up to 1yr.
• Lokelma is an insoluble- non-absorbed sodium zirconium silicate- formulated as a powder for oral suspension and acts as a highly selective potassium-removing medicine and is an approved therapy for the treatment of hyperkalemia in the US- EU- Canada- Hong Kong- China- Russia and Japan

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