AstraZeneca’s Lokelma Receives CHMP’s Recommendation for Approval for Patients with Hyperkalemia on Stable Hemodialysis

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

Click here to­ read full press release/ article | Ref: AstraZeneca | Image: Strait Times