AstraZeneca's Lokelma Receives Fast Track Designation for the Treatment of Chronic Haemodialysis with Hyperkalaemia
- The designation is based on the ongoing P-III DIALIZE-Outcomes trial to evaluate the effect of Lokelma on arrhythmia-related CV outcomes in patients with chronic hemodialysis with recurrent HK at 300 sites across the US, Canada, Russia, EU, Asia & South America
- The therapy is designed to reduce serious adverse CV outcomes. The results are expected in 2024
- Lokelma is a highly selective, oral potassium-removing agent & is approved in the US, EU, Canada, Hong Kong, China, Russia, Japan & other countries for HK. In 2020, the therapy received the US FDA and EC's approval for label updates in the US & EU to include a dosing regimen to treat HK in patients with ESRD on chronic hemodialysis
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