FDA News

FDA accepts NDA for roxadustat for CKD-related anemia

The FDA has accepted a new drug application for roxadustat, a drug already approved for the treatment of chronic kidney disease-related anemia in China, according to a press release from FibroGen Inc. The NDA applies to both nondialysis dependent CKD (NDD-CKD) patients and patients on dialysis.

“The FDA’s acceptance of the roxadustat new drug application is a critical step towards providing a new treatment option in the United States for chronic kidney disease patients suffering from anemia, a serious and often life-threatening disease,” Enrique Conterno, CEO of FibroGen, said.

According to the release, AstraZeneca will now make a $50 million milestone payment to FibroGen.

“There is significant unmet medical need for patients with anemia of CKD, who have seen only limited advances in the last 3 decades,” Peony Yu, MD, chief medical officer of FibroGen, said. “We intend to work closely with the FDA, in collaboration with our partner, AstraZeneca, to make this novel oral therapy available as soon as possible.”

 

Reference:

www.globenewswire.com/news-release/2020/02/11/1983461/0/en/FibroGen-Announces-U-S-FDA-Acceptance-of-New-Drug-Application-for-Roxadustat-for-the-Treatment-of-Anemia-of-Chronic-Kidney-Disease.html

The FDA has accepted a new drug application for roxadustat, a drug already approved for the treatment of chronic kidney disease-related anemia in China, according to a press release from FibroGen Inc. The NDA applies to both nondialysis dependent CKD (NDD-CKD) patients and patients on dialysis.

“The FDA’s acceptance of the roxadustat new drug application is a critical step towards providing a new treatment option in the United States for chronic kidney disease patients suffering from anemia, a serious and often life-threatening disease,” Enrique Conterno, CEO of FibroGen, said.

According to the release, AstraZeneca will now make a $50 million milestone payment to FibroGen.

“There is significant unmet medical need for patients with anemia of CKD, who have seen only limited advances in the last 3 decades,” Peony Yu, MD, chief medical officer of FibroGen, said. “We intend to work closely with the FDA, in collaboration with our partner, AstraZeneca, to make this novel oral therapy available as soon as possible.”

 

Reference:

www.globenewswire.com/news-release/2020/02/11/1983461/0/en/FibroGen-Announces-U-S-FDA-Acceptance-of-New-Drug-Application-for-Roxadustat-for-the-Treatment-of-Anemia-of-Chronic-Kidney-Disease.html