US FDA Rejects to Give Approval to Anemia Drug Developed by FibroGen

On Wednesday, 11^th August 2021, the company ‘FibroGen Inc.’, said the United States Food and Drug Administration has rejected the approval for the drug of the company for the treatment of the anemia of chronic kidney disease, that has been citing the need for an additional study.

In July 2021, a panel of the experts in the FDA have voted against the approval of the drug candidate known as ‘roxadustat’, which the company has been developing in the partnership with the pharmaceutical giant ‘AstraZeneca’.

And with the rejection of the drug, the shares of the company have been decreased by 2.5 percent following the negative decision by the regulator of the United States, and in the meeting of the experts panel, the FDA has also raised the concerns about the safety and effectiveness of the drug, that has been already approved in the countries including Japan, China, South Korea, and Chile.

In July 2021, another rival drug known as daprodustat, that was developed by the company ‘GSK’ have succeeded in the late-stage trials, and the trails have shown the improved levels of haemoglobin in the patients, who had not received any standard care and have also helped in maintaining the levels of haemoglobin in those patients who did.

The Roxadustat drug has been the first of a new kind of the treatment of oral anemia that has been responsible for boosting the production of the red blood cells by copying the response of the body to the high altitude.