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AstraZeneca plc (LSE:AZN; NYSE:AZN) said FDA accepted a resubmitted NDA for ZS-9 to treat hyperkalemia. In May, AZ received a complete response letter in which FDA cited "observations arising from a pre-approval manufacturing inspection" (see BioCentury Extra, May 27).
ZS-9 is an inorganic crystal form of zirconium silicate designed to trap potassium ions over other ions throughout the GI tract. The pharma did not respond to an inquiry about the candidate's new PDUFA date or manufacturing changes.
AZ gained ZS-9 in 4Q15 through its $2.7 billion acquisition of ZS Pharma Inc.
FDA approved competing hyperkalemia treatment Veltassa patiromer in October 2015. Galenica Ltd. (SIX:GALN) has since obtained rights to Veltassa, a high-capacity oral potassium binder, through its acquisition of Relypsa Inc. (NASDAQ:RLYP). That deal completed last month (see BioCentury Extra, July 21).
Original Article: FDA again reviewing AZ's hyperkalemia candidateNEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
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