Bone and Mineral Metabolism Disorders
Two years after the FDA turned down an application for its hyperkalemia drug ZS-9, AstraZeneca announced on March 22 that it has received approval for the drug from the European Commission under its new name, Lokelma. AstraZeneca said in a press release that it hopes to get U.S. approval for the drug later this year.
The company paid $2.7 billion for ZS Pharma in November 2015 to gain access to ZS-9 and compete with Relypsa’s Veltassa, which received FDA approval in October of that year. In May 2016, the FDA rejected the application for ZS-9, citing manufacturing-related issues. AstraZeneca said the problems were not related to the clinical trials.
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This activity is supported by an educational grant from ViiV Healthcare.
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