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FDA Committee Votes Against AstraZeneca’s Anemia Treatment (2)

July 16, 2021, 11:42 AM

AstraZeneca Plc was dealt a blow as an advisory committee of the Food and Drug Administration said it doesn’t support the approval of treatment for anemia in patients with chronic kidney disease.

The Cardiovascular and Renal Drugs Advisory Committee voted 13 to 1 that the benefits and risk of AstraZeneca’s roxadustat don’t support approval for non-dialysis dependent patients, the company said in a statement. Similarly, the vote was 12 to 2 against the use of roxadustat in dialysis-dependent patients.

The decision comes after the company and its partner FibroGen Inc. were accused of overstating the safety profile of the anemia ...