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U.S. FDA declines to approve Akebia’s anemia drug on safety concerns


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Reuters - 30/03/2022 - The U.S. health regulator has declined to approve Akebia Therapeutics' drug to treat anemia caused by chronic kidney disease on safety concerns in non-dialysis patients, the company said on Wednesday. The drugmaker's shares plunged about 73% to a record low of 67 cents in afternoon trade. Vadadustat was inferior in its safety profile when compared with the current standard of care for patients not dependent on dialysis, the U.S. Food and Drug Administration noted. The drug posed an increased risk of blood clot formations and drug-induced injuries to the liver, the agency added. Vadadustat is the second drug from the HIF-PH (Hypoxia-Inducible Factor Prolyl Hydroxylase) inhibitor class to be rejected by the FDA, after FibroGen-AstraZeneca's roxadustat in August 2021. The regulator indicated in its letter that Akebia could explore conducting new studies to potentially show a favorable benefit-risk assessment of the drug. ...


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