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AstraZeneca's ZS-9 Timeline Hit By FDA Complete Response Letter

 
• By Sten Stovall

A manufacturing issue at a plant in Texas has resulted in a complete response letter from the FDA, dashing AstraZeneca's hopes that its potential best-in-class treatment for hyperkalemia, ZS-9, would be approved in this year's first half – but the good news is that no new clinical data is required on the drug.

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The regulatory timeline for AstraZeneca PLC's promising potassium-binding compound ZS-9 has been derailed for the time being by a complete response letter from the FDA due to manufacturing deficiencies found by investigators during a pre-approval inspection at a plant making the medicine in Coppell, Texas.

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