AstraZeneca: FDA Calls for Extra Clinical Trial on Safety of Roxadustat

 AstraZeneca PLC said Wednesday that the U.S. Food and Drug Administration has asked for an extra clinical trial of roxadustat for the treatment of anemia of chronic kidney disease before it can approve the company's new drug application.

The pharmaceutical giant said that it is working with its partner FibroGen Inc. to evaluate the next steps.

AstraZeneca added that the safety and effectiveness of roxadustat has been demonstrated in a Phase 3 program in more than 8,000 patients.

Roxadustat is already approved in a number of countries, including China and Japan, and is under regulatory review in the European Union and other jurisdictions, the company said.

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