Shots:

• The EMA’s CHMP has adopted a positive opinion on a dosing and administration label update for AstraZeneca’s Lokelma to include patients with hyperkalemia on stable hemodialysis
• The recommendation is based on P-IIIb DIALIZE study assessing Lokelma (qd) vs PBO in 196 patients on non-dialysis days for 8wks. The study demonstrated that patients-maintained pre-dialysis potassium levels on at least 3 out of 4 dialysis treatments- following the long interdialytic interval and did not require urgent rescue therapy (41% vs 1%)
• 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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