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.
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.
Still, the British drug maker – which acquired the asset when it bought US-based ZS Pharma Inc. last year...
After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.
Recent moves in the industry include changes at the top at iOnctura and Orca Bio, plus Sutro Biopharma, Tenpoint Therapeutics and Helix BioPharma get new CFOs.
Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.
