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AstraZeneca’s ZS-9 Delay In US Gives Veltassa An Edge

 
• By Jessica Merrill

FDA issued a second complete response letter to AstraZeneca’s NDA for ZS-9 for hyperkalaemia, a potential blockbuster that would compete against Vifor Pharma’s Veltassa.

3-D Rendering Red Blood Cells

AstraZeneca PLC received a second complete response letter from FDA on the NDA for ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia, a potential blockbuster drug it paid handsomely to acquire. The delay, announced by AstraZeneca March 17, will give rival Galenica Group’s Veltassa (patiromer) more time to dominate the hyperkalaemia market.

ZS-9 was granted a recommendation for approval by the European Committee for Medicinal Products for Human Use (CHMP) in February, but approval in the US has been hung up by a manufacturing issue. (Also see "AZ’s ZS-9 Targets Hyperkalemia Sector As It Nears EU Market" - Scrip, 24 February, 2017

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